The following data is part of a premarket notification filed by Bio Spec, Inc. with the FDA for Bio Spec Gramafluor Test Kit.
| Device ID | K860091 |
| 510k Number | K860091 |
| Device Name: | BIO SPEC GRAMAFLUOR TEST KIT |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | BIO SPEC, INC. 179 MASON CIRCLE #A Concord, CA 94520 |
| Contact | Robert F Hird |
| Correspondent | Robert F Hird BIO SPEC, INC. 179 MASON CIRCLE #A Concord, CA 94520 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-10 |
| Decision Date | 1986-01-21 |