The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device.
Device ID | K010841 |
510k Number | K010841 |
Device Name: | ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE |
Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
Applicant | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
Contact | Robert Hudak |
Correspondent | Robert Hudak ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
Product Code | DIO |
CFR Regulation Number | 862.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-21 |
Decision Date | 2001-07-09 |