IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)

System, Test, Radioallergosorbent (rast) Immunological

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immunlite 2000 Allergen-specific Ige And Mixed Allergen Panels, Model L2kun6 (600 Tests).

Pre-market Notification Details

Device IDK013135
510k NumberK013135
Device Name:IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
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 CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-19
Decision Date2001-10-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414965529 K013135 000
00630414960371 K013135 000
00630414960401 K013135 000
00630414960432 K013135 000
00630414960609 K013135 000
00630414960623 K013135 000
00630414960678 K013135 000
00630414965086 K013135 000
00630414965352 K013135 000
00630414965376 K013135 000
00630414965505 K013135 000
00630414959856 K013135 000

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