URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)

Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase

ASTORIA-PACIFIC,INC.

The following data is part of a premarket notification filed by Astoria-pacific,inc. with the FDA for Uridyltransferase Kit, 50 Hour (80-4000-13k).

Pre-market Notification Details

Device IDK970277
510k NumberK970277
Device Name:URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
ClassificationFluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase
Applicant ASTORIA-PACIFIC,INC. 14600 S.E. 82ND DR. Clackamas,  OR  97015 -0830
ContactRaymond L Pavitt
CorrespondentRaymond L Pavitt
ASTORIA-PACIFIC,INC. 14600 S.E. 82ND DR. Clackamas,  OR  97015 -0830
Product CodeKQP  
CFR Regulation Number862.1315 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-23
Decision Date1997-12-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00725609000182 K970277 000
00725609000175 K970277 000
00725609000168 K970277 000
00725609000151 K970277 000
00725609000069 K970277 000
00725609000052 K970277 000
00725609000045 K970277 000

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