The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Capik-candida Albicans Ident. Kit..
| Device ID | K800908 |
| 510k Number | K800908 |
| Device Name: | CAPIK-CANDIDA ALBICANS IDENT. KIT. |
| Classification | Kit, Identification, Yeast |
| Applicant | IMMUNO-MYCOLOGICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JXB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-21 |
| Decision Date | 1980-06-02 |