The following data is part of a premarket notification filed by American Scientific Products with the FDA for Streptacoccus Co-agglutination Kit.
| Device ID | K822799 |
| 510k Number | K822799 |
| Device Name: | STREPTACOCCUS CO-AGGLUTINATION KIT |
| Classification | Exoenzymes, Multiple, Streptococcal |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GTP |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-16 |
| Decision Date | 1982-12-19 |