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510(k) K842537

VON WILLEBRAND FACTOR ANTIGEN SCREEN by American Dade — Product Code ICF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1984
Date Received
June 28, 1984
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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  • K872195 — DATA-FI DIMERTEST LATEX ASSAY (August 6, 1987)
  • K872196 — AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III (July 31, 1987)
  • K871972 — STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (July 21, 1987)
  • K871977 — DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR (July 9, 1987)
  • K872050 — PARAMAX CHOLESTEROL REAGENT (July 7, 1987)
  • K872360 — DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (July 6, 1987)

Other clearances for product code ICF

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  • K821503 — IRIS URINE STAIN (June 3, 1982)
  • K792495 — VOLU-SOL URINARY SEDIMENT STAIN (December 18, 1979)