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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

K092283 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG". The FDA issued a decision of Substantially Equivalent on October 21, 2009. The device falls under product code DFZ (Igg (Gamma Chain Specific), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.

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)

FDA data resources