K991650 is an FDA 510(k) clearance for the CMV BRITE TURBO KIT. This device is classified as a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II - Special Controls, product code LIN).
Submitted by Biotest Diagnostics Corp. (Denville, US). The FDA issued a Cleared decision on July 12, 1999, 60 days after receiving the submission on May 13, 1999.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K991650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1999 |
| Decision Date | July 12, 1999 |
| Days to Decision | 60 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LIN — Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |