K860279 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT. This device is classified as a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II - Special Controls, product code LIN).
Submitted by Bartels Immunodiagnostic Supplies, Inc. (Bellevue, US). The FDA issued a Cleared decision on May 13, 1986, 119 days after receiving the submission on January 14, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K860279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1986 |
| Decision Date | May 13, 1986 |
| Days to Decision | 119 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 |