Submission Details
| 510(k) Number | K093357 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
Jun 2010
Decision
239d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
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