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510(k) K844402

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

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

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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 GIA

  • K931241 — FAST'N'FLAMMATORY KIT (February 3, 1994)
  • K811011 — HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE (May 15, 1981)