CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3— 510(k) K090283
Substantially EquivalentGenchem, Inc.
FDA 510(k) clearance K090283 for CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3, Substantially Equivalent on 2009-06-05. Applicant: Genchem, Inc.. Device class: 2.
Clearance details
- Applicant
- Genchem, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Brea, CA, US
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