K900743 is an FDA 510(k) clearance for the CMV-IGM IFA TEST SYSTEM. This device is classified as a Antibody Igm,if, Cytomegalovirus Virus (Class II - Special Controls, product code LKQ).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on April 26, 1990, 69 days after receiving the submission on February 16, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K900743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1990 |
| Decision Date | April 26, 1990 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LKQ — Antibody Igm,if, Cytomegalovirus Virus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |