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510(k) K844402

SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR by Sigma Chemical Co. — Product Code GIA

K844402 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR". The FDA issued a decision of Substantially Equivalent on January 4, 1985. 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
January 4, 1985
Date Received
November 13, 1984
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)
  • K811011 — HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE (May 15, 1981)

FDA data resources