The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Chrom Z Chromogenic Assays.
| Device ID | K951943 |
| 510k Number | K951943 |
| Device Name: | CHROM Z CHROMOGENIC ASSAYS |
| Classification | Antithrombin Iii Quantitation |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Pat Franks |
| Correspondent | Pat Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-26 |
| Decision Date | 1995-11-13 |