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510(k) K811011

HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE by Sigma Chemical Co. — Product Code GIA

K811011 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE". The FDA issued a decision of Substantially Equivalent on May 15, 1981. The device falls under product code GIA (Test, Leukocyte Peroxidase), a Class I device regulated under 21 CFR 864.7675. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1981
Date Received
April 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Leukocyte Peroxidase
Device Class
Class I
Regulation Number
864.7675
Review Panel
PA
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 GIA

  • K931241 — FAST'N'FLAMMATORY KIT (February 3, 1994)
  • K844402 — SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR (January 4, 1985)

FDA data resources