The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Marijuana (thc) Urine Dip Strip Test.
| Device ID | K994410 |
| 510k Number | K994410 |
| Device Name: | INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 11494 SORRENTO VALLEY RD., SUITE F/M San Diego, CA 92121 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 11494 SORRENTO VALLEY RD., SUITE F/M 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 | 1999-12-28 |
| Decision Date | 2000-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00667742820008 | K994410 | 000 |
| 00677421820007 | K994410 | 000 |