K974552 is an FDA 510(k) clearance for the DIAMEDIX IS-MEASLES IGG TEST SYSTEM. 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 January 28, 1998, 55 days after receiving the submission on December 4, 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 | K974552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 1997 |
| Decision Date | January 28, 1998 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| 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. |