Clear Aid
Catalogue number 5005, listed by Helena Laboratories, Corp., United States, under Agent, Clearing. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
Record
| Listed by | Helena Laboratories, Corp., United States |
|---|---|
| FDA product code | KEM |
| Device type | Agent, Clearing |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-03-17 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5005 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 17 |
| Agent, Clearing | Scientific Device Laboratory, Inc. | 6 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 5 |
| Remel | Remel, Inc. | 1 |
| EliA Stool Extraction Buffer plus | Phadia AB | 1 |
| PermaClear Clearing Solution | Helena Laboratories, Corp. | 1 |
| Alpha-Tec Systems | Alpha-Tec Systems, Inc. | 1 |
| Cardinal Health | Cardinal Health 200, LLC | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K861490 | 1986-05-06 |
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.