K820390 is an FDA 510(k) clearance for the HISTOSET IMMUNOPEROXIDASE TISSURE KIT. This device is classified as a Antisera, Immunoperoxidase, Chlamydia Spp. (Class I - General Controls, product code LKH).
Submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1982, 63 days after receiving the submission on February 10, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K820390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1982 |
| Decision Date | April 14, 1982 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LKH — Antisera, Immunoperoxidase, Chlamydia Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |