Submission Details
| 510(k) Number | K212221 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 16, 2021 |
| Decision Date | December 13, 2021 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
Dec 2021
Decision
150d
Days
Class 2
Risk
About This 510(k) Submission
K212221 is an FDA 510(k) clearance for the Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on December 13, 2021, 150 days after receiving the submission on July 16, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.
Device Classification
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1155 |
Manufacturer
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