The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for On Call Home Drug Test For Marijuana And On Call Home Drug Test For Marijuana And Cocaine.
| Device ID | K050936 |
| 510k Number | K050936 |
| Device Name: | ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-14 |
| Decision Date | 2005-06-24 |
| Summary: | summary |