Submission Details
| 510(k) Number | K160762 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 21, 2016 |
| Decision Date | November 21, 2016 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
Nov 2016
Decision
245d
Days
Class 2
Risk
About This 510(k) Submission
K160762 is an FDA 510(k) clearance for the Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on November 21, 2016, 245 days after receiving the submission on March 21, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.
Device Classification
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7470 |
Manufacturer
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