The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Sta D-di Calibrator Kit.
| Device ID | K964718 |
| 510k Number | K964718 |
| Device Name: | STA D-DI CALIBRATOR KIT |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, 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 | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-25 |
| Decision Date | 1997-05-23 |
| Summary: | summary |