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 |