The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for At-iii Calibrator.
| Device ID | K944279 |
| 510k Number | K944279 |
| Device Name: | AT-III CALIBRATOR |
| Classification | Antithrombin Iii Quantitation |
| 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 | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-30 |
| Decision Date | 1995-04-07 |