The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Enzygnost(r) Tat Reagents.
| Device ID | K880700 |
| 510k Number | K880700 |
| Device Name: | ENZYGNOST(R) TAT REAGENTS |
| Classification | Antithrombin Iii Quantitation |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-22 |
| Decision Date | 1988-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768013065 | K880700 | 000 |