AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA

Autoantibodies, Endomysial(tissue Transglutaminase)

HYCOR BIOMEDICAL LTD.

The following data is part of a premarket notification filed by Hycor Biomedical Ltd. with the FDA for Autostat Ii Anti-tissue Transglutaminase Igg Elisa.

Pre-market Notification Details

Device IDK043433
510k NumberK043433
Device Name:AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
ClassificationAutoantibodies, Endomysial(tissue Transglutaminase)
Applicant HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN Edinburgh,  GB Eh26 Opl
ContactDanielle M Knight
CorrespondentDanielle M Knight
HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN Edinburgh,  GB Eh26 Opl
Product CodeMVM  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-13
Decision Date2005-03-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879020267 K043433 000

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