The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Accucolor(tm) Antithrombin Iii Chromogenic Assay.
| Device ID | K935308 |
| 510k Number | K935308 |
| Device Name: | ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY |
| Classification | Antithrombin Iii Quantitation |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Daniel E Lawson |
| Correspondent | Daniel E Lawson SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-02 |
| Decision Date | 1994-05-17 |