StatSensor/StatStrip
StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies v1.0
3manufacturers in China registered for this device type
5catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (1), Hunan (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Eaglenos Sciences, Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Nova Biomedical Corporation, United States |
|---|---|
| FDA product code | KHP |
| Device type | Acid, Lactic, Enzymatic Method |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1450 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K150281 |
| Record published | 2016-09-20 |
| Record revised | 2019-08-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.75 | In distribution | |
| 1.0 | In distribution | |
| 1.75 | In distribution | |
| 1.0 | In distribution | |
| 1.0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 5 |
| Lactate Gen.2 | Roche Diagnostics Gmbh | 4 |
| Lactate Plus | Nova Biomedical Corporation | 4 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 3 |
| i-STAT | Abbott Point OF Care Inc. | 3 |
| Alinity | Abbott Medical | 2 |
| Fora | Fora Care Inc. | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| LA Cartridge | LifeHealth, LLC | 2 |
| L-Lactate (LAC) | Randox Laboratories Limited | 2 |
| ABX Pentra Lactic Acid | Horiba ABX SAS | 1 |
| Alinity | Abbott Ireland | 1 |
Showing 12 of 43. All products under Acid, Lactic, Enzymatic Method
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112955 | 2012-01-05 |
| K100602 | 2011-08-17 |
| K936066 | 1995-03-09 |
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.