Alpha-Tec Systems
Microvials PVA (Zn) Fix/10% Formalin 50 sets
3manufacturers in China registered for this device type
34catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
Record
| Listed by | Alpha-Tec Systems, Inc., United States |
|---|---|
| FDA product code | LDZ |
| Device type | Fixative, Alcohol Containing |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| 510(k) | K881698 |
| Record published | 2022-08-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0 | 50 | In distribution | |
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | 50 | In distribution | |
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | 50 | In distribution | |
| 0 | 36 | In distribution | |
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | 25 | In distribution | |
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | 25 | In distribution | |
| 0 | In distribution | ||
| 0 | 20 | In distribution | |
| 0 | 50 | In distribution | |
| 0 | 50 | In distribution | |
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | In distribution | ||
| 0 | 32 | In distribution | |
| 0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fixative, Alcohol Containing | Scientific Device Laboratory, Inc. | 7 |
| Epredia | Richard-Allan Scientific LLC | 5 |
| Camco | Cambridge Diagnostic Products, Inc. | 2 |
| Tissue-Tek Xpress® | Sakura Finetek U.S.A., Inc. | 2 |
| Barrx | Covidien LP | 2 |
| Thermo Scientific Protocol™ Parasitology System | Fisher Diagnostics | 2 |
| Chemical Service Labs, LLC | Protean Resources, LLC. | 2 |
| Alinity | Abbott Laboratories | 1 |
| Hobbs Medical Saccomanno Cell Transport System | Hobbs Medical, Inc. | 1 |
| PVA (Zn) Fix/10% Formalin 25 sets | Alpha-Tec Systems, Inc. | 1 |
| Tissue-Tek Xpress® x120 | Sakura Finetek U.S.A., Inc. | 1 |
| BD CytoRich™ Red Preservative | Becton, Dickinson AND Company | 1 |
Showing 12 of 14. All products under Fixative, Alcohol Containing
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K883048 | 1988-08-17 |
| K881698 | 1988-05-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.