The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Sta System Control [n] + [p] Kit.
| Device ID | K943518 |
| 510k Number | K943518 |
| Device Name: | STA SYSTEM CONTROL [N] + [P] KIT |
| Classification | Plasma, Coagulation Control |
| 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 | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-21 |
| Decision Date | 1995-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450006780 | K943518 | 000 |