K910290 is an FDA 510(k) clearance for the VIRATEST-DIA(TM) MEASLES (RUBEOLA). This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (Class I - General Controls, product code LJB).
Submitted by Virus Reference Laboratory, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 18, 1992, 421 days after receiving the submission on January 22, 1991.
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 | K910290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1991 |
| Decision Date | March 18, 1992 |
| Days to Decision | 421 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. |