K904036 is an FDA 510(k) clearance for the BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN. This device is classified as a Antisera, Conjugated Fluorescent, Cytomegalovirus (Class II - Special Controls, product code LIN).
Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on October 16, 1990, 41 days after receiving the submission on September 5, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K904036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1990 |
| Decision Date | October 16, 1990 |
| Days to Decision | 41 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 |