DEMAND ACID PHOSPHATASE REAGENT— 510(k) K853949
Substantially EquivalentCooper Biomedical, Inc.
FDA 510(k) clearance K853949 for DEMAND ACID PHOSPHATASE REAGENT, Substantially Equivalent on 1985-10-16. Applicant: Cooper Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Cooper Biomedical, Inc.
- Product code
- Code CKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.1020
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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