The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Strep B Polyvalent Fluoro-kit.
| Device ID | K801876 |
| 510k Number | K801876 |
| Device Name: | STREP B POLYVALENT FLUORO-KIT |
| Classification | Antisera, Fluorescent, All Groups, Streptococcus Spp. |
| Applicant | CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTX |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-05 |
| Decision Date | 1980-09-16 |