IRON STANDARD
FDA 510(k) clearance K052002 · decided 2005-08-22
Clearance details
- K-number
- K052002
- Device name
- IRON STANDARD
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-25
- Decision date
- 2005-08-22
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- JIT
- Device class
- 2
- Regulation number
- 862.1150
- 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.
PMA approvals by this applicant
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