Submission Details
| 510(k) Number | K123785 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 10, 2012 |
| Decision Date | June 07, 2013 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET
Jun 2013
Decision
179d
Days
Class 2
Risk
About This 510(k) Submission
K123785 is an FDA 510(k) clearance for the DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET, a Myoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDR), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on June 7, 2013, 179 days after receiving the submission on December 10, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5680.
Device Classification
| Product Code | DDR — Myoglobin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5680 |
Manufacturer
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