IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6

Enzyme Immunoassay, Valproic Acid

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Valproic Acid, Immulite 2000 Valproic Acid, Catalog # Lkva1, Lkva5 & L2kva2, L2kva6.

Pre-market Notification Details

Device IDK000005
510k NumberK000005
Device Name:IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
ClassificationEnzyme Immunoassay, Valproic Acid
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 CodeLEG  
CFR Regulation Number862.3645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-03
Decision Date2000-03-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414964850 K000005 000
00630414962290 K000005 000

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