IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR

System, Test, Immunological, Antigen, Tumor

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Br-ma, Model #lkbr; Immulite 2000 Br-ma, Model #l2kbr.

Pre-market Notification Details

Device IDK013984
510k NumberK013984
Device Name:IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR
ClassificationSystem, Test, Immunological, Antigen, Tumor
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 CodeMOI  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-03
Decision Date2002-03-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414963655 K013984 000
00630414961088 K013984 000
00630414953601 K013984 000

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