K961204 is an FDA 510(k) clearance for the MUMPS IGG TEST. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Mumps Virus (Class I - General Controls, product code LJY).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on July 18, 1996, 113 days after receiving the submission on March 27, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3380.
| 510(k) Number | K961204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1996 |
| Decision Date | July 18, 1996 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LJY — Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3380 |