COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
FDA 510(k) clearance K061048 · decided 2006-05-17
Clearance details
- K-number
- K061048
- Device name
- COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-17
- Decision date
- 2006-05-17
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- CFR
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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