The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Modification To Instant-view Methamphetyamine (meth1000) Urine Test (cassette).
| Device ID | K003847 |
| 510k Number | K003847 |
| Device Name: | MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) |
| Classification | Gas Chromatography, Methamphetamine |
| Applicant | ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Contact | Naishu Wang |
| Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. Poway, CA 92064 |
| Product Code | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-12 |
| Decision Date | 2001-05-29 |