K903961 is an FDA 510(k) clearance for the MEASLES IGG MICROASSAY. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (Class I - General Controls, product code LJB).
Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on December 28, 1990, 122 days after receiving the submission on August 28, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3520. The Qualitative Detection Of Measles Specific Igg Antibodies In Serum Or Plasma..
| 510(k) Number | K903961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1990 |
| Decision Date | December 28, 1990 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LJB — Enzyme Linked Immunoabsorbent Assay, Rubeola Igg |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3520 |
| Definition | The Qualitative Detection Of Measles Specific Igg Antibodies In Serum Or Plasma. |