K821411 is an FDA 510(k) clearance for the HISTOSET IMMUNOPEROFIDASE TISSUE. This device is classified as a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II - Special Controls, product code GQL).
Submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982, 44 days after receiving the submission on May 12, 1982.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K821411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1982 |
| Decision Date | June 25, 1982 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |