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510(k) K040976

GENCHEM CREATININE REAGENT by Genchem, Inc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2004
Date Received
April 14, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Genchem, Inc.

  • K090283 — CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 (June 5, 2009)
  • K040975 — GENCHEM CO2 ACID REAGENT (December 27, 2004)
  • K040972 — CALCIUM, AZO DYE REAGENT (December 27, 2004)
  • K040974 — GLUCOSE OXIDASE, GLUCOSE (December 27, 2004)
  • K040977 — GENCHEM ELECTROLYTE BUFFER (December 27, 2004)
  • K040973 — BUN REAGENT (December 27, 2004)
  • K040971 — GENCHEM ISE ELECTROLYTE REFERENCE (December 22, 2004)

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