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510(k) K864531

TISSUE GRAM STAIN by Sigma Diagnostics, Inc. — Product Code ICF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1986
Date Received
November 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crystal Violet For Histology
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

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  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (November 15, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (November 15, 2001)
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  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (March 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)

Other clearances for product code ICF

  • K842537 — VON WILLEBRAND FACTOR ANTIGEN SCREEN (October 1, 1984)
  • K842730 — GENTIAN VIOLET (August 3, 1984)
  • K821503 — IRIS URINE STAIN (June 3, 1982)
  • K792495 — VOLU-SOL URINARY SEDIMENT STAIN (December 18, 1979)