CRP-WELLCOTEST— 510(k) K771139
Substantially EquivalentBurroughs Wellcome Co.
FDA 510(k) clearance K771139 for CRP-WELLCOTEST, Substantially Equivalent on 1977-07-14. Applicant: Burroughs Wellcome Co.. Device class: 2.
Clearance details
- Applicant
- Burroughs Wellcome Co.
- Product code
- Code DCN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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