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510(k) K830645

BLEEDING TIME DEVICE DISPOSABLE by American Dade — Product Code JCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1983
Date Received
March 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Bleeding Time
Device Class
Class II
Regulation Number
864.6100
Review Panel
HE
Submission Type

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  • 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 JCA

  • K911745 — SIMPLATE PEDIATRIC (August 9, 1991)
  • K911996 — SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION (July 17, 1991)
  • K871318 — Q.I.C. BLEEDING TIME DEVICE (June 10, 1987)
  • K850542 — SURGICUTT - BLEEDING TIME DEVICE (March 1, 1985)
  • K801815 — AUTOLET (October 10, 1980)
  • K761250 — SIMPLATE (March 1, 1977)