K993706 is an FDA 510(k) clearance for the ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY. This device is classified as a Column Chromatography & Color Development, Hydroxyproline (Class I - General Controls, product code JMM).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 24, 2000, 265 days after receiving the submission on November 2, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1400.
| 510(k) Number | K993706 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1999 |
| Decision Date | July 24, 2000 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JMM — Column Chromatography & Color Development, Hydroxyproline |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1400 |