DeviceClearance

CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3— 510(k) K090283

Substantially Equivalent

Genchem, 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..

Clearance details

Applicant
Genchem, Inc.
Product code
Code JIX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Brea, CA, US
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