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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