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510(k) K803272

Device
AUTOMATED IMMUNOPRECIPITIN METHOD/ICG
Applicant
ICL SCIENTIFIC
510(k) number
K803272
Product code
DFZ  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-26
Date received
1980-12-29
Regulation
866.5510
Classification name
Igg (gamma Chain Specific), Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DFZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092283DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGGSiemens Healthcare Diagnostics2009-10-21
K021081HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSERThe Binding Site, Ltd.2002-06-17
K020823PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KITSanquin Blood Supply Foundation2002-05-14
K955906BOEHRINGER MANNHEIM IGG ASSAYBoehringer Mannheim Corp.1996-02-09
K940422IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZERThe Binding Site, Ltd.1994-05-27
K812821H-103 IGG, H-104 IGA, H-105 IGMImmulok, Inc.1981-10-26
K790709ANTISERUM TO RABBIT IMMUNOGLOBULINKent Laboratories, Inc.1979-08-16
K790720ANTISERA TO RABBIT IMMUNOGLOBULINKent Laboratories, Inc.1979-08-16

Legacy Summary#

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FDA Review#

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