CHOLESTEROL ASSSAY KIT
FDA 510(k) clearance K842160 · decided 1984-08-17
Clearance details
- K-number
- K842160
- Device name
- CHOLESTEROL ASSSAY KIT
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1984-05-30
- Decision date
- 1984-08-17
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Canada, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: recall (Z-0711-2011) | Diagnostic Chemicals, Ltd. | 2010-12-16 |