The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Oxy Ii One Step Oxycodone Test Strip; Test Device.
Device ID | K043507 |
510k Number | K043507 |
Device Name: | ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE |
Classification | Enzyme Immunoassay, Opiates |
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 | DJG |
CFR Regulation Number | 862.3650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-12-20 |
Decision Date | 2005-02-25 |
Summary: | summary |