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 |