The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Gen. Diag. Chromostrate Antithrombin Iii Assay.
| Device ID | K850412 |
| 510k Number | K850412 |
| Device Name: | GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY |
| Classification | Antithrombin Iii Quantitation |
| Applicant | WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
| Contact | Lynn Decaro |
| Correspondent | Lynn Decaro WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-04 |
| Decision Date | 1985-05-08 |