The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Tca Urine Test.
Device ID | K022693 |
510k Number | K022693 |
Device Name: | INSTANT-VIEW TCA URINE TEST |
Classification | Thin Layer Chromatography, Tricyclic Antidepressant Drugs |
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 | MLK |
CFR Regulation Number | 862.3910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-13 |
Decision Date | 2002-12-09 |
Summary: | summary |