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510(k) K090283

CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 by Genchem, Inc. — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2009
Date Received
February 5, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K040973 — BUN REAGENT (December 27, 2004)
  • K040976 — GENCHEM CREATININE REAGENT (December 27, 2004)
  • K040971 — GENCHEM ISE ELECTROLYTE REFERENCE (December 22, 2004)

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