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510(k) K092283

DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG by Siemens Healthcare Diagnostics — Product Code DFZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 21, 2009
Date Received: July 29, 2009
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

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)
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)
K790709 — ANTISERUM TO RABBIT IMMUNOGLOBULIN (August 16, 1979)
K790720 — ANTISERA TO RABBIT IMMUNOGLOBULIN (August 16, 1979)