The following data is part of a premarket notification filed by Bartels Immunodiagnostic Supplies, Inc. with the FDA for Cytotoxicity Assay For Clostridium-.
Device ID | K833447 |
510k Number | K833447 |
Device Name: | CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- |
Classification | Antigen, C. Difficile |
Applicant | BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | MCB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-05 |
Decision Date | 1984-05-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05391516748858 | K833447 | 000 |
05391516748841 | K833447 | 000 |
05391516747998 | K833447 | 000 |
05391516747950 | K833447 | 000 |