IMMULITE THYROID AUTOANTIBODY CONTROL MODULE

Single (specified) Analyte Controls (assayed And Unassayed)

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Thyroid Autoantibody Control Module.

Pre-market Notification Details

Device IDK971051
510k NumberK971051
Device Name:IMMULITE THYROID AUTOANTIBODY CONTROL MODULE
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
ContactEdward M Levine
CorrespondentEdward M Levine
DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-24
Decision Date1997-04-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414953335 K971051 000

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