K925209 is an FDA 510(k) clearance for the MUMPS STAT. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Mumps Virus (Class I - General Controls, product code LJY).
Submitted by Biowhittaker Molecular Applications, Inc. (Walkersville, US). The FDA issued a Cleared decision on October 14, 1994, 737 days after receiving the submission on October 7, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3380.
| 510(k) Number | K925209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1992 |
| Decision Date | October 14, 1994 |
| Days to Decision | 737 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 |