RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)— 510(k) K871269
Substantially EquivalentTechnicon Instruments Corp.
FDA 510(k) clearance K871269 for RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C), Substantially Equivalent on 1987-04-13. Applicant: Technicon Instruments Corp.. Device class: 2.
Clearance details
- Applicant
- Technicon Instruments Corp.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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