The following data is part of a premarket notification filed by Bio Spec, Inc. with the FDA for Bio Spec Strep-a-fluor Test Kit.
| Device ID | K841479 |
| 510k Number | K841479 |
| Device Name: | BIO SPEC STREP-A-FLUOR TEST KIT |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | BIO SPEC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-09 |
| Decision Date | 1984-04-25 |