The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Bup One Step Buprenorphine Test Strip And Acron Bup One Step Buprenorphine Test Device.
Device ID | K060466 |
510k Number | K060466 |
Device Name: | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE 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 | 2006-02-22 |
Decision Date | 2006-04-21 |
Summary: | summary |