K894002 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY. 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 August 10, 1989, 66 days after receiving the submission on June 5, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K894002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1989 |
| Decision Date | August 10, 1989 |
| 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 |