DIASTAT ANTI-LA (SS-B)

Anti-rnp Antibody, Antigen And Control

SHIELD DIAGNOSTICS, LTD.

The following data is part of a premarket notification filed by Shield Diagnostics, Ltd. with the FDA for Diastat Anti-la (ss-b).

Pre-market Notification Details

Device IDK905193
510k NumberK905193
Device Name:DIASTAT ANTI-LA (SS-B)
ClassificationAnti-rnp Antibody, Antigen And Control
Applicant SHIELD DIAGNOSTICS, LTD. TECHNOLOGY PARK DUNDEE DD2 1SW Scotland,  KN 77359
ContactGeorge Zajicek
CorrespondentGeorge Zajicek
SHIELD DIAGNOSTICS, LTD. TECHNOLOGY PARK DUNDEE DD2 1SW Scotland,  KN 77359
Product CodeLKO  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-19
Decision Date1990-12-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07340058410011 K905193 000

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