The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for St-4 Coagulation Instrument.
| Device ID | K904297 |
| 510k Number | K904297 |
| Device Name: | ST-4 COAGULATION INSTRUMENT |
| Classification | Instrument, Coagulation, Automated |
| Applicant | AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Contact | Loc B Le |
| Correspondent | Loc B Le AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-19 |
| Decision Date | 1990-11-13 |