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510(k) K903995

NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT by Sigma Chemical Co. — Product Code GHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1990
Date Received
August 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Leukocyte Alkaline Phosphatase
Device Class
Class I
Regulation Number
864.7660
Review Panel
HE
Submission Type

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

Other clearances for product code GHD

  • K904022 — NITRO BLUE TETRAZOLIUM REDUCTION (December 18, 1990)
  • K896092 — ALKALINE PHOSPHATASE, LEUKOCYTE, KIT (November 9, 1989)
  • K811189 — CHEMSTRIP L (July 27, 1981)