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510(k) K933691

SIGMA CO2 ALKALINE BUFFER REAGENT by Sigma Chemical Co. — Product Code JFL

K933691 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "SIGMA CO2 ALKALINE BUFFER REAGENT". The FDA issued a decision of Substantially Equivalent on December 17, 1993. The device falls under product code JFL (Ph Rate Measurement, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1993
Date Received
July 29, 1993
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 Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)
  • K933702 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 (October 8, 1993)

Other clearances for product code JFL

  • K191298 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)
  • K040975 — GENCHEM CO2 ACID REAGENT (December 27, 2004)
  • 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)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)

FDA data resources