The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Ppx One Step Propoxyphene Test Strip And Acon Ppx Step Propoxyphene Test Device.
Device ID | K040445 |
510k Number | K040445 |
Device Name: | ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE |
Classification | Enzyme Immunoassay, Propoxyphene |
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 | JXN |
CFR Regulation Number | 862.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-20 |
Decision Date | 2004-05-19 |
Summary: | summary |