FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
FDA 510(k) clearance K864882 · decided 1987-01-21
Clearance details
- K-number
- K864882
- Device name
- FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 1986-12-12
- Decision date
- 1987-01-21
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- JIY
- Device class
- 1
- Regulation number
- 862.1410
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Detroit, MI, US
- Third-party review
- No
- Expedited review
- No
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