The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view H. Pylori One Step Rapid Test.
Device ID | K024360 |
510k Number | K024360 |
Device Name: | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST |
Classification | Helicobacter Pylori |
Applicant | ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
Contact | Naishu Wang |
Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
Product Code | LYR |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-30 |
Decision Date | 2003-06-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10673486002393 | K024360 | 000 |