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510(k) K761250

SIMPLATE by General Diagnostics — Product Code JCA

K761250 is an FDA 510(k) premarket notification submitted by General Diagnostics for the device "SIMPLATE". The FDA issued a decision of Substantially Equivalent on March 1, 1977. The device falls under product code JCA (Device, Bleeding Time), a Class II device regulated under 21 CFR 864.6100. General Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1977
Date Received
December 13, 1976
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

Other clearances by General Diagnostics

  • K882663 — BARBITURATE ENZYME IMMUNOASSAY KIT (September 19, 1988)
  • K872882 — CANNABINOID ENZYME IMMUNOASSAY KIT (November 3, 1987)
  • K871305 — COCAINE METABOLITE ENZYME IMMUNOASSAY KIT (June 5, 1987)
  • K864993 — QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE (March 31, 1987)
  • K863877 — BENZODIAZEPINE ENZYME IMMUNOASSAY KIT (March 12, 1987)
  • K842307 — GENERAL DIAG. CEFONICID 30MCG ANTIMIC (July 20, 1984)
  • K841465 — GENERAL DIAGNOSTICS PLATELET ANTIBODY (July 2, 1984)
  • K833709 — CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK (December 30, 1983)
  • K832653 — CEFUROXIME 30MCG. SUSCEP DISK (October 14, 1983)
  • K831179 — CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP (May 9, 1983)

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)
  • K830645 — BLEEDING TIME DEVICE DISPOSABLE (March 17, 1983)
  • K801815 — AUTOLET (October 10, 1980)

FDA data resources