FDA 510(k)

H-103 IGG, H-104 IGA, H-105 IGM

K-Number: K812821 · 1981-10-26

Decision Date1981-10-26

Product CodeDFZ

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

H-103 IGG, H-104 IGA, H-105 IGM is the device name listed in this FDA 510(k) record. The listed applicant is Immulok, Inc.. It received FDA 510(k) clearance on 1981-10-26 under 510(k) number K812821. The device is classified under product code DFZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H-103 IGG, H-104 IGA, H-105 IGM?

H-103 IGG, H-104 IGA, H-105 IGM is a medical device that received FDA 510(k) clearance on 1981-10-26. The listed applicant is Immulok, Inc.. The 510(k) number is K812821.

When did H-103 IGG, H-104 IGA, H-105 IGM receive FDA 510(k) clearance?

H-103 IGG, H-104 IGA, H-105 IGM received FDA 510(k) clearance on 1981-10-26, under 510(k) number K812821.

Who is the listed applicant for H-103 IGG, H-104 IGA, H-105 IGM?

The FDA 510(k) record lists Immulok, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-103 IGG, H-104 IGA, H-105 IGM?

The FDA product code for H-103 IGG, H-104 IGA, H-105 IGM is DFZ.

Other records listing Immulok, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K830971HERPES SIMPLEX VIRUS TYPING REAGENTS K830342CULUTURE SET CHLAMYDIA ISOLATION AND K830250CVT VIRAL TRANSPORTS K823304RIASET PROLACTIN RIA KIT K822785FLUOROSET IMMUNOFLUORESCENT ANTIBODY K823055FLOUROSET IMMUNOFLUORESCENT ANTIBODY

View all 15 devices →

Related Devices (Code: DFZ)

K092283DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGGSiemens Healthcare Diagnostics K021081HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSERThe Binding Site, Ltd.K020823PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KITSanquin Blood Supply Foundation K955906BOEHRINGER MANNHEIM IGG ASSAYBoehringer Mannheim Corp.K940422IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZERThe Binding Site, Ltd.K803272AUTOMATED IMMUNOPRECIPITIN METHOD/ICGIcl Scientific

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.