ARCHITECT CA 15-3 ASSAY

System, Test, Immunological, Antigen, Tumor

FUJIREBIO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Architect Ca 15-3 Assay.

Pre-market Notification Details

Device IDK042732
510k NumberK042732
Device Name:ARCHITECT CA 15-3 ASSAY
ClassificationSystem, Test, Immunological, Antigen, Tumor
Applicant FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern,  PA  19355 -1307
ContactKimberly Peterson
CorrespondentKimberly Peterson
FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. Malvern,  PA  19355 -1307
Product CodeMOI  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-01
Decision Date2004-12-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740145330 K042732 000
00380740003326 K042732 000
00380740003333 K042732 000
00380740003340 K042732 000
00380740003357 K042732 000
00380740131432 K042732 000
00380740131449 K042732 000
00380740145293 K042732 000
00380740145309 K042732 000
00380740145316 K042732 000
00380740145323 K042732 000
00380740003319 K042732 000

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