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510(k) K021081

HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER by The Binding Site, Ltd. — Product Code DFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2002
Date Received
April 3, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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Other clearances for product code DFZ

  • K092283 — DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION (October 21, 2009)
  • K020823 — PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT (May 14, 2002)
  • K955906 — BOEHRINGER MANNHEIM IGG ASSAY (February 9, 1996)
  • K940422 — IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALY (May 27, 1994)
  • K812821 — H-103 IGG, H-104 IGA, H-105 IGM (October 26, 1981)
  • K803272 — AUTOMATED IMMUNOPRECIPITIN METHOD/ICG (January 26, 1981)
  • K790720 — ANTISERA TO RABBIT IMMUNOGLOBULIN (August 16, 1979)
  • K790709 — ANTISERUM TO RABBIT IMMUNOGLOBULIN (August 16, 1979)