The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Sta Compact Automated Multi-parametric Analyzer.
| Device ID | K961579 |
| 510k Number | K961579 |
| Device Name: | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER |
| Classification | Instrument, Coagulation, Automated |
| Applicant | AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Andrew Loc B Le, Ph.d. |
| Correspondent | Andrew Loc B Le, Ph.d. AMERICAN BIOPRODUCTS CO. 5 CENTURY DR. 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 | 1996-04-24 |
| Decision Date | 1996-07-10 |
| Summary: | summary |