The following data is part of a premarket notification filed by Ind Diagnostic Inc. with the FDA for One Step Drug Test - Amp/met/mor/thc/coc.
| Device ID | K060810 |
| 510k Number | K060810 |
| Device Name: | ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | IND DIAGNOSTIC INC. 1629 FOSTERS WAY Delta, Bc, CA V3m 6s7 |
| Contact | Jason Peng |
| Correspondent | Jason Peng IND DIAGNOSTIC INC. 1629 FOSTERS WAY Delta, Bc, CA V3m 6s7 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-24 |
| Decision Date | 2006-08-07 |