The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Sta Liatest Control [n]+[p] Kit.
| Device ID | K964716 |
| 510k Number | K964716 |
| Device Name: | STA LIATEST CONTROL [N]+[P] KIT |
| Classification | Plasma, Coagulation Control |
| Applicant | AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Andrew Loc Be Le |
| Correspondent | Andrew Loc Be Le AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-25 |
| Decision Date | 1997-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450005264 | K964716 | 000 |