The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Mtd One Step Methadone Test Strip And Test Device.
Device ID | K012595 |
510k Number | K012595 |
Device Name: | ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE |
Classification | Enzyme Immunoassay, Methadone |
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 | DJR |
CFR Regulation Number | 862.3620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-10 |
Decision Date | 2001-10-15 |
Summary: | summary |