The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Star Automated Multi-parametric Analyzer.
| Device ID | K983460 |
| 510k Number | K983460 |
| Device Name: | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-30 |
| Decision Date | 1998-11-12 |
| Summary: | summary |