K822606 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS ANTOBODY IGG. This device is classified as a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II - Special Controls, product code LIN).
Submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1982, 66 days after receiving the submission on August 27, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K822606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1982 |
| Decision Date | November 01, 1982 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LIN — Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |