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510(k) K020823

PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT by Sanquin Blood Supply Foundation — Product Code DFZ

K020823 is an FDA 510(k) premarket notification submitted by Sanquin Blood Supply Foundation for the device "PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT". The FDA issued a decision of Substantially Equivalent on May 14, 2002. The device falls under product code DFZ (Igg (Gamma Chain Specific), Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2002
Date Received
March 14, 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

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)
  • 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