Submission Details
| 510(k) Number | K900743 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 16, 1990 |
| Decision Date | April 26, 1990 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
Cleared
Traditional
CMV-IGM IFA TEST SYSTEM
Apr 1990
Decision
69d
Days
Class 2
Risk
About This 510(k) Submission
K900743 is an FDA 510(k) clearance for the CMV-IGM IFA TEST SYSTEM, 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 review panel. Regulated under 21 CFR 866.3175.
Device Classification
| Product Code | LKQ — Antibody Igm,if, Cytomegalovirus Virus |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3175 |
Manufacturer
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