The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Antithrombin Iii Chromogenic Assay.
| Device ID | K936196 |
| 510k Number | K936196 |
| Device Name: | ANTITHROMBIN III CHROMOGENIC ASSAY |
| Classification | Antithrombin Iii Quantitation |
| Applicant | BAXTER DIAGNOSTICS, INC. 1851 DELAWARE PKWY. Miami, FL 33125 |
| Contact | Ronald H Lentsch, Ph.d |
| Correspondent | Ronald H Lentsch, Ph.d BAXTER DIAGNOSTICS, INC. 1851 DELAWARE PKWY. Miami, FL 33125 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-29 |
| Decision Date | 1994-05-04 |