Submission Details
| 510(k) Number | K961204 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
MUMPS IGG TEST
Jul 1996
Decision
113d
Days
Class 1
Risk
About This 510(k) Submission
K961204 is an FDA 510(k) clearance for the MUMPS IGG TEST, 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 review panel. Regulated under 21 CFR 866.3380.
Device Classification
| Product Code | LJY — Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3380 |
Manufacturer
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