Home / 510(k) Clearances / K871318

510(k) K871318

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

K871318 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "Q.I.C. BLEEDING TIME DEVICE". The FDA issued a decision of Substantially Equivalent on June 10, 1987. The device falls under product code JCA (Device, Bleeding Time), a Class II device regulated under 21 CFR 864.6100. Helena Laboratories has at least 10 other 510(k) clearances on record.

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

Other clearances by Helena Laboratories

  • K213396 — SPIFE A1AT kit (October 13, 2022)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

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)

FDA data resources