The following data is part of a premarket notification filed by Bio Spec, Inc. with the FDA for Strep D Fluor.
| Device ID | K860041 |
| 510k Number | K860041 |
| Device Name: | STREP D FLUOR |
| Classification | Exoenzymes, Multiple, Streptococcal |
| 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 | GTP |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-01-24 |