K924289 is an FDA 510(k) clearance for the KALLESTAD RSV MICROPLATE EIA. This device is classified as a Respiratory Syncytial Virus - Elisa (Class I - General Controls, product code MCE).
Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on February 12, 1993, 175 days after receiving the submission on August 21, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3480.
| 510(k) Number | K924289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1992 |
| Decision Date | February 12, 1993 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MCE — Respiratory Syncytial Virus - Elisa |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3480 |