K821762 is an FDA 510(k) clearance for the MEASELISA TEST KIT. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (Class I - General Controls, product code LJB).
Submitted by M.A. Bioproducts (Walker, US). The FDA issued a Cleared decision on July 30, 1982, 45 days after receiving the submission on June 15, 1982.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3520. The Qualitative Detection Of Measles Specific Igg Antibodies In Serum Or Plasma..
| 510(k) Number | K821762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1982 |
| Decision Date | July 30, 1982 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| 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. |