Home / 510(k) Clearances / K834024

510(k) K834024

HEPARINOMETER by Western Laboratories Corp. — Product Code KFF

K834024 is an FDA 510(k) premarket notification submitted by Western Laboratories Corp. for the device "HEPARINOMETER". The FDA issued a decision of Substantially Equivalent on June 11, 1984. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525. Western Laboratories Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1984
Date Received
November 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Heparin
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

Other clearances by Western Laboratories Corp.

  • K830468 — MODEL 200 (April 12, 1983)
  • K821834 — MODEL 100 BICARBONATE CONDUCTIVITY (July 2, 1982)
  • K821414 — MODEL 80 BC (May 27, 1982)
  • K821415 — MODEL 90 BC (May 27, 1982)
  • K801303 — MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST (July 28, 1980)
  • K780932 — MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT (August 31, 1978)

Other clearances for product code KFF

  • K213464 — HemosIL Liquid Anti-Xa (October 4, 2022)
  • K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Hep (August 22, 2017)
  • K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / (October 26, 2011)
  • K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS (June 2, 2009)
  • K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 (May 24, 2006)
  • K013305 — ENOXAPARIN TEST CARD (August 23, 2002)
  • K013637 — ACTICHROME HEPARIN (ANTI-FIIA) (April 16, 2002)
  • K013318 — ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (March 8, 2002)
  • K010455 — ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (June 7, 2001)
  • K010193 — HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (June 6, 2001)

FDA data resources