The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Quikstrip Dipscan X Multidrug Screening Device.
| Device ID | K990325 |
| 510k Number | K990325 |
| Device Name: | QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | SYNTRON BIORESEARCH, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird SYNTRON BIORESEARCH, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-02 |
| Decision Date | 1999-06-24 |
| Summary: | summary |