K880029 is an FDA 510(k) clearance for the EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001. This device is classified as a Antiserum, Positive Control, Blastomyces Dermatitidis (Class II - Special Controls, product code KFH).
Submitted by Immuno-Mycologics, Inc. (Norman, US). The FDA issued a Cleared decision on February 24, 1988, 50 days after receiving the submission on January 5, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3060.
| 510(k) Number | K880029 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1988 |
| Decision Date | February 24, 1988 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | KFH — Antiserum, Positive Control, Blastomyces Dermatitidis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3060 |