COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2

Radioimmunoassay, Immunoglobulins (d, E)

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Coat-a-count Total Ige Irma, Catalog #ikie1, Ikie2.

Pre-market Notification Details

Device IDK901859
510k NumberK901859
Device Name:COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2
ClassificationRadioimmunoassay, Immunoglobulins (d, E)
Applicant DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
ContactB Asarch,phd
CorrespondentB Asarch,phd
DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
Product CodeJHR  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-24
Decision Date1990-05-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414953458 K901859 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.