IMMULITE SHBG (MODIFICATION)

Radioimmunoassay, Testosterones And Dihydrotestosterone

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Shbg (modification).

Pre-market Notification Details

Device IDK955440
510k NumberK955440
Device Name:IMMULITE SHBG (MODIFICATION)
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
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 CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-23
Decision Date1995-12-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414998947 K955440 000
00630414972831 K955440 000
00630414972916 K955440 000
00630414966557 K955440 000
00630414954226 K955440 000

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