K915700 is an FDA 510(k) clearance for the PERMIER HISTOPLASMA. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum (Class II - Special Controls, product code MIZ).
Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on July 30, 1992, 220 days after receiving the submission on December 23, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3320.
| 510(k) Number | K915700 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1991 |
| Decision Date | July 30, 1992 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | MIZ — Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3320 |