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 |