The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon H. Pylori Rapid Test Strip And Acon H. Pylori Rapid Test Device.
| Device ID | K024350 |
| 510k Number | K024350 |
| Device Name: | ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE |
| Classification | Helicobacter Pylori |
| Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Edward Tung |
| Correspondent | Edward Tung ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| 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 | 2003-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066000304 | K024350 | 000 |