The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Cali-loop.
| Device ID | K820345 |
| 510k Number | K820345 |
| Device Name: | CALI-LOOP |
| Classification | Device, General Purpose, Microbiology, Diagnostic |
| Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-08 |
| Decision Date | 1982-03-04 |