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510(k) K871318

Q.I.C. BLEEDING TIME DEVICE by Helena Laboratories — Product Code JCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1987
Date Received
April 3, 1987
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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Other clearances for product code JCA

  • K911745 — SIMPLATE PEDIATRIC (August 9, 1991)
  • K911996 — SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION (July 17, 1991)
  • K850542 — SURGICUTT - BLEEDING TIME DEVICE (March 1, 1985)
  • K830645 — BLEEDING TIME DEVICE DISPOSABLE (March 17, 1983)
  • K801815 — AUTOLET (October 10, 1980)
  • K761250 — SIMPLATE (March 1, 1977)