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510(k) K903995

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

K903995 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT". The FDA issued a decision of Substantially Equivalent on December 13, 1990. The device falls under product code GHD (Test, Leukocyte Alkaline Phosphatase), a Class I device regulated under 21 CFR 864.7660. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

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

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)
  • 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)

FDA data resources