K984139 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II - Special Controls, product code LFZ).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 11, 1999, 54 days after receiving the submission on November 18, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3175.
| 510(k) Number | K984139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1998 |
| Decision Date | January 11, 1999 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3175 |