COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY— 510(k) K851942
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K851942 for COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY, Substantially Equivalent on 1985-05-31. Applicant: Coulter Electronics, Inc.. Device class: 1.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
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