K830837 is an FDA 510(k) clearance for the LA-HISTO ANTIBODY SYSTEM #HL 1001. This device is classified as a Antigens, Histoplasma Capsulatum, All (Class II - Special Controls, product code GMJ).
Submitted by Immuno-Mycologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 5, 1983, 50 days after receiving the submission on March 16, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3320.
| 510(k) Number | K830837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 1983 |
| Decision Date | May 05, 1983 |
| Days to Decision | 50 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 |