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510(k) K843752

SIGMA PERIODIC ACID-SCHIFF STAIN 395 by Sigma Chemical Co. — Product Code HZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1984
Date Received
September 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Schiff
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

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  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
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  • 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)

Other clearances for product code HZT

  • K883217 — SCHIFF REAGENT (August 5, 1988)
  • K842919 — SCHIFF REAGENT FUCHSIN-SULFUROUS ACID (September 11, 1984)
  • K842917 — SCHIFF REAGENT, PAS STAIN (September 7, 1984)
  • K760031 — HISTOCHEMICAL PAS REACTION SET (July 20, 1976)