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510(k) K933696

SIGMA ELECTROLYTE REFERENCE REAGENT by Sigma Chemical Co. — Product Code JFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1994
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

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  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)
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  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)