The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Sta-coag Control [p] Plus Kit.
| Device ID | K952338 |
| 510k Number | K952338 |
| Device Name: | STA-COAG CONTROL [P] PLUS KIT |
| Classification | Control, Plasma, Abnormal |
| Applicant | AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Andrew Loc B. Le |
| Correspondent | Andrew Loc B. Le AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-19 |
| Decision Date | 1995-09-21 |