K802130 is an FDA 510(k) clearance for the IMMUNO. IDENTIFICATION OF H. CAPSULATUM. This device is classified as a Antigens, Histoplasma Capsulatum, All (Class II - Special Controls, product code GMJ).
Submitted by Nolan Biological Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980, 53 days after receiving the submission on August 4, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3320.
| 510(k) Number | K802130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1980 |
| Decision Date | September 26, 1980 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GMJ — Antigens, Histoplasma Capsulatum, All |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3320 |