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510(k) K003767

ASSERACHROM HPIA TEST KIT by Diagnostica Stago, Inc. — Product Code LCO

K003767 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "ASSERACHROM HPIA TEST KIT". The FDA issued a decision of Substantially Equivalent on February 12, 2001. The device falls under product code LCO (Platelet Factor 4 Radioimmunoassay), a Class II device regulated under 21 CFR 864.7695. Diagnostica Stago, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2001
Date Received
December 6, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Platelet Factor 4 Radioimmunoassay
Device Class
Class II
Regulation Number
864.7695
Review Panel
HE
Submission Type

Other clearances by Diagnostica Stago, Inc.

  • K253658 — STA Satellite Max® (April 27, 2026)
  • K212183 — STA R Max 3, STA Compact Max 3 (June 7, 2023)
  • K211485 — STA- NeoPTimal (December 23, 2022)
  • K162227 — STA® - Liatest® D-Di (December 10, 2016)
  • K151867 — STA R MAX (August 7, 2015)
  • K141144 — STA LIATEST D-DI (September 3, 2014)
  • K120014 — STA- COAG CONTROL (N+ABN) PLUS (March 14, 2013)
  • K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / (October 26, 2011)
  • K092937 — STA-HYBRID HEP CALIBRATOR (August 2, 2010)
  • K093167 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (December 22, 2009)

Other clearances for product code LCO

  • K243374 — HemosIL CL HIT-IgG(PF4-H) (January 28, 2025)
  • K201570 — PF4 Enhanced assay (September 11, 2020)
  • K201311 — PF4 IgG assay (June 18, 2020)
  • K170854 — HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls (September 8, 2017)
  • K153137 — HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls (July 8, 2016)
  • K071781 — PF4 IGG (December 19, 2007)
  • K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (September 7, 2007)
  • K053559 — PF4 ENHANCED SOLID PHASE ELISA (January 20, 2006)
  • K040293 — HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY (May 28, 2004)
  • K983379 — GTI-PF4 ELISA (March 9, 1999)

FDA data resources