K093357 is an FDA 510(k) clearance for the DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D. 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 June 24, 2010, 239 days after receiving the submission on October 28, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K093357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2009 |
| Decision Date | June 24, 2010 |
| Days to Decision | 239 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 |