FDA 510(k) Applications for Medical Device Product Code "LFG"
(Radioimmunoassay, Tricyclic Antidepressant Drugs)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K021526 | ACON LABORATORIES, INC. | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE | 07/17/2002 |
| K142609 | Guangzhou Wondfo Biotech Co., Ltd. | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | 12/18/2014 |
| K112395 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST | 09/09/2011 |
| K151348 | HEALGEN SCIENTIFIC LLC | Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) | 08/18/2015 |
| K011545 | MEDTOX DIAGNOSTICS, INC. | VERDICT -II TCA, VERDICT-II MTD | 06/08/2001 |
| K980249 | PRINCETON BIOMEDITECH CORP. | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | 03/13/1998 |
| K072062 | UCP BIOSCIENCES, INC. | UCP MULTIPLE DRUG SCREEN TEST CUPS | 09/20/2007 |
| K061457 | UCP BIOSCIENCES, INC. | UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS | 08/21/2006 |
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