K922335 is an FDA 510(k) clearance for the BARTELS RUBEOLA IGM EIA. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (Class I - General Controls, product code LJB).
Submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on September 2, 1992, 112 days after receiving the submission on May 13, 1992.
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 | K922335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1992 |
| Decision Date | September 02, 1992 |
| Days to Decision | 112 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. |