LIGHTCYCLER INSTRUMENT VERSION 1.2
FDA 510(k) clearance K033734 · decided 2003-12-17
Clearance details
- K-number
- K033734
- Device name
- LIGHTCYCLER INSTRUMENT VERSION 1.2
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-28
- Decision date
- 2003-12-17
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- JJF
- Device class
- 1
- Regulation number
- 862.2170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCyc recall (Z-0459-2008) | Roche Diagnostics Corp. | 2007-12-12 |
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