K101365 is an FDA 510(k) clearance for the ELECSYS CA 19-9 CALCHECK 5. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I - General Controls, product code JJX).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 5, 2010, 141 days after receiving the submission on May 17, 2010.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K101365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2010 |
| Decision Date | October 05, 2010 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |