The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Accu-staph.
Device ID | K820347 |
510k Number | K820347 |
Device Name: | ACCU-STAPH |
Classification | Staphylococcus Aureus Somatic Antigens |
Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LHT |
CFR Regulation Number | 866.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-08 |
Decision Date | 1982-03-04 |