COULTER LD (LDH-L) REAGENT— 510(k) K897164
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K897164 for COULTER LD (LDH-L) REAGENT, Substantially Equivalent on 1990-03-09. Applicant: Coulter Electronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code CFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
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More clearances from Coulter Electronics, Inc.
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