FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
K Number: K212221
·
Decision Dec 13, 2021
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
11
Review Days
150
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
- K Number
- K212221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diazyme Laboratories, Inc.
- Date Received
- July 16, 2021
- Decision Date
- December 13, 2021
- Product Code
- DHA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHA), ordered by most recent decision date.
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Total ßhCG (5th IS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys HCG STAT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Diazyme Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253069 | Lipoprotein (a) Molarity Assay | Jun 16, 2026 | Substantially Equivalent |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | Apr 24, 2026 | Substantially Equivalent |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Dec 19, 2025 | Substantially Equivalent |
| K243462 | Diazyme Colorimetric Lithium Assay | Aug 1, 2025 | Substantially Equivalent |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Sep 8, 2022 | Substantially Equivalent |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Aug 4, 2022 | Substantially Equivalent |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | Aug 6, 2021 | Substantially Equivalent |
| K180209 | Diazyme 1,5-AG Assay | Oct 4, 2018 | Substantially Equivalent |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | Jun 26, 2018 | Substantially Equivalent |
| K180074 | Diazyme Lipoprotein (a) Assay | Mar 22, 2018 | Substantially Equivalent |