K896355 is an FDA 510(k) clearance for the CMV IGM ELISA TEST SYSTEM. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II - Special Controls, product code LFZ).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on February 27, 1990, 113 days after receiving the submission on November 6, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K896355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1989 |
| Decision Date | February 27, 1990 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |