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).
Device ID | K970277 |
510k Number | K970277 |
Device Name: | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) |
Classification | Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase |
Applicant | ASTORIA-PACIFIC,INC. 14600 S.E. 82ND DR. Clackamas, OR 97015 -0830 |
Contact | Raymond L Pavitt |
Correspondent | Raymond L Pavitt ASTORIA-PACIFIC,INC. 14600 S.E. 82ND DR. Clackamas, OR 97015 -0830 |
Product Code | KQP |
CFR Regulation Number | 862.1315 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-01-23 |
Decision Date | 1997-12-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00725609000182 | K970277 | 000 |
00725609000175 | K970277 | 000 |
00725609000168 | K970277 | 000 |
00725609000151 | K970277 | 000 |
00725609000069 | K970277 | 000 |
00725609000052 | K970277 | 000 |
00725609000045 | K970277 | 000 |