The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Quikstrip Onestep Marijuana (thc) Test.
| Device ID | K963654 |
| 510k Number | K963654 |
| Device Name: | QUIKSTRIP ONESTEP MARIJUANA (THC) TEST |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | SYNTRON BIORESEARCH, INC. 3216 SHERI DR. Simi Valley, CA 93063 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird SYNTRON BIORESEARCH, INC. 3216 SHERI DR. Simi Valley, CA 93063 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-12 |
| Decision Date | 1997-02-28 |
| Summary: | summary |