SERA-210 ELECTROLYTE ANALYZER— 510(k) K853356
Substantially EquivalentHoriba Instruments, Inc.
FDA 510(k) clearance K853356 for SERA-210 ELECTROLYTE ANALYZER, Substantially Equivalent on 1985-09-03. Applicant: Horiba Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Horiba Instruments, Inc.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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