IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06

Acid, Folic, Radioimmunoassay

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2000 Folic Acid, Model L2kf02, L2kf06.

Pre-market Notification Details

Device IDK993254
510k NumberK993254
Device Name:IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
ClassificationAcid, Folic, Radioimmunoassay
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 CodeCGN  
CFR Regulation Number862.1295 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-28
Decision Date1999-11-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414961491 K993254 000
00630414961484 K993254 000
00630414954455 K993254 000

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