K111650 is an FDA 510(k) clearance for the IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS.... This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX).
Submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on September 6, 2011, 85 days after receiving the submission on June 13, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K111650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2011 |
| Decision Date | September 06, 2011 |
| Days to Decision | 85 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |