The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Thrombo-calibrator Kit.
| Device ID | K921344 |
| 510k Number | K921344 |
| Device Name: | THROMBO-CALIBRATOR KIT |
| Classification | Plasma, Coagulation Control |
| 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 | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-19 |
| Decision Date | 1992-06-09 |