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510(k) K890633

ENZYGNOST PLATELET FACTOR 4 (PF4) KIT by Behring Diagnostics, Inc. — Product Code LCO

K890633 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "ENZYGNOST PLATELET FACTOR 4 (PF4) KIT". The FDA issued a decision of Substantially Equivalent on April 21, 1989. The device falls under product code LCO (Platelet Factor 4 Radioimmunoassay), a Class II device regulated under 21 CFR 864.7695. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1989
Date Received
February 8, 1989
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 Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

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)
  • K003767 — ASSERACHROM HPIA TEST KIT (February 12, 2001)

FDA data resources