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510(k) K040975

GENCHEM CO2 ACID REAGENT by Genchem, Inc. — Product Code JFL

K040975 is an FDA 510(k) premarket notification submitted by Genchem, Inc. for the device "GENCHEM CO2 ACID REAGENT". The FDA issued a decision of Substantially Equivalent on December 27, 2004. The device falls under product code JFL (Ph Rate Measurement, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Genchem, Inc. has at least 7 other 510(k) clearances on record.

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
Ph Rate Measurement, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
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)
  • K040976 — GENCHEM CREATININE REAGENT (December 27, 2004)
  • K040977 — GENCHEM ELECTROLYTE BUFFER (December 27, 2004)
  • K040973 — BUN REAGENT (December 27, 2004)
  • K040972 — CALCIUM, AZO DYE REAGENT (December 27, 2004)
  • K040974 — GLUCOSE OXIDASE, GLUCOSE (December 27, 2004)
  • K040971 — GENCHEM ISE ELECTROLYTE REFERENCE (December 22, 2004)

Other clearances for product code JFL

  • K191298 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)
  • K014034 — MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (December 18, 2001)
  • K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT (October 24, 1996)
  • K963538 — SIGMA DIAGNOSTICS CO2ALKALINE BUFFER (October 11, 1996)
  • K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFER (September 27, 1996)
  • K963005 — NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) (August 23, 1996)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)

FDA data resources