The following data is part of a premarket notification filed by Kabi Pharmacia Hepar, Inc. with the FDA for Coatest(r) Antithrombin Iii, Modification.
| Device ID | K931420 |
| 510k Number | K931420 |
| Device Name: | COATEST(R) ANTITHROMBIN III, MODIFICATION |
| Classification | Antithrombin Iii Quantitation |
| Applicant | KABI PHARMACIA HEPAR, INC. 160 INDUSTRIAL DR. Franklin, OH 45005 |
| Contact | Madeleine Burmester |
| Correspondent | Madeleine Burmester KABI PHARMACIA HEPAR, INC. 160 INDUSTRIAL DR. Franklin, OH 45005 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1994-05-02 |