K971620 is an FDA 510(k) clearance for the QUANTA LITE RUBEOLA (MEASLES) IGG. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (Class I - General Controls, product code LJB).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on July 22, 1997, 82 days after receiving the submission on May 1, 1997.
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 | K971620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1997 |
| Decision Date | July 22, 1997 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| 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. |