UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
FDA 510(k) clearance K973692 · decided 1998-02-09
Clearance details
- K-number
- K973692
- Device name
- UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE
- Applicant
- United Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-26
- Decision date
- 1998-02-09
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.