IMMULITE ANTI-TG AB

System, Test, Thyroid Autoantibody

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Anti-tg Ab.

Pre-market Notification Details

Device IDK980206
510k NumberK980206
Device Name:IMMULITE ANTI-TG AB
ClassificationSystem, Test, Thyroid Autoantibody
Applicant DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
ContactEdward M Levine, Ph.d.
CorrespondentEdward M Levine, Ph.d.
DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
Product CodeJZO  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-20
Decision Date1998-05-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414964676 K980206 000

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