TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
FDA 510(k) clearance K922722 · decided 1992-10-05
Clearance details
- K-number
- K922722
- Device name
- TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL
- Applicant
- Simplicity Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-05
- Decision date
- 1992-10-05
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Hatboro, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.