CRP-WELLCOTEST
FDA 510(k) clearance K771139 · decided 1977-07-14
Clearance details
- K-number
- K771139
- Device name
- CRP-WELLCOTEST
- Applicant
- Burroughs Wellcome Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-06-27
- Decision date
- 1977-07-14
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- DCN
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.