The following data is part of a premarket notification filed by Kabi Pharmacia, Inc. with the FDA for Coamate(r) Antithrombin Chromogenic Assay.
| Device ID | K915083 |
| 510k Number | K915083 |
| Device Name: | COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY |
| Classification | Antithrombin Iii Quantitation |
| Applicant | KABI PHARMACIA, INC. 160 INDUSTRIAL DR. Franklin, OH 45005 |
| Contact | Kevin M Foley |
| Correspondent | Kevin M Foley KABI PHARMACIA, 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 | 1991-11-12 |
| Decision Date | 1992-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950088868 | K915083 | 000 |