The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Fast'n'flammatory Kit.
| Device ID | K931241 |
| 510k Number | K931241 |
| Device Name: | FAST'N'FLAMMATORY KIT |
| Classification | Test, Leukocyte Peroxidase |
| Applicant | TECHLAB, INC. VPI RESEARCH PARK 1861 PRATT DR. Blacksburg, VA 24060 |
| Contact | Tracy Wilkins |
| Correspondent | Tracy Wilkins TECHLAB, INC. VPI RESEARCH PARK 1861 PRATT DR. Blacksburg, VA 24060 |
| Product Code | GIA |
| CFR Regulation Number | 864.7675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-11 |
| Decision Date | 1994-02-03 |