K133751 is an FDA 510(k) clearance for the DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on August 8, 2014, 242 days after receiving the submission on December 9, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K133751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2013 |
| Decision Date | August 08, 2014 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT - Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |