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510(k) K940422

IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER by The Binding Site, Ltd. — Product Code DFZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
January 19, 1994
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)
  • K021081 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIME (June 17, 2002)
  • K020823 — PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT (May 14, 2002)
  • K955906 — BOEHRINGER MANNHEIM IGG ASSAY (February 9, 1996)
  • K812821 — H-103 IGG, H-104 IGA, H-105 IGM (October 26, 1981)
  • K803272 — AUTOMATED IMMUNOPRECIPITIN METHOD/ICG (January 26, 1981)
  • K790709 — ANTISERUM TO RABBIT IMMUNOGLOBULIN (August 16, 1979)
  • K790720 — ANTISERA TO RABBIT IMMUNOGLOBULIN (August 16, 1979)