Panels › Clinical Toxicology › Product code LDJ · Class 2
Enzyme Immunoassay, Cannabinoids
Regulation 862.3870
0510(k)s in 12 months (150 all time)
0recalls in 12 months (15 all time)
12recalls that name a 510(k)
Top companies in LDJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 5, 2001 | K010001 | LIVESURE THC SCREEN TEST Pan Probe Biotech, Inc. | LDJ |
| Jan 26, 2001 | K002375 | STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I OraSure Technologies, Inc. | LDJ |
| Nov 27, 2000 | K002263 | BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST Branan Medical Corp. | LDJ |
| Aug 7, 2000 | K001126 | PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST Alatex Scientific, Inc. | LDJ |
| Jun 23, 2000 | K994139 | FIRST CHECK HOME DRUG TEST PANEL 2 Worldwide Medical Corp. | LDJ |
| Jun 23, 2000 | K994138 | FIRST CHECK HOME DRUG TEST PANEL 3 Worldwide Medical Corp. | LDJ |
| Jun 23, 2000 | K993663 | FIRST CHECK HOME DRUG TEST (THC) Worldwide Medical Corp. | LDJ |
| Jun 21, 2000 | K994410 | INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | LDJ |
| Jun 19, 2000 | K001567 | ADVANTAGE THC TEST Advantage Diagnostics Corp. | LDJ |
| Apr 13, 2000 | K994164 | ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 Roche Diagnostics Corp. | LDJ |
| Apr 6, 2000 | K000461 | URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A Dade Behring, Inc. | LDJ |
| Feb 4, 2000 | K000131 | QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 Phamatech | LDJ |
| Jan 24, 2000 | K993961 | RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO) American Bio Medica Corp. | LDJ |
| Jan 18, 2000 | K993984 | SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL Syva Co. | LDJ |
| Dec 30, 1999 | K994220 | AT HOME DRUG TEST, MODEL 9078 Phamatech | LDJ |
| Dec 27, 1999 | K992949 | SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST Drug Detection Devices, Ltd. | LDJ |
| Dec 21, 1999 | K993796 | RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE American Bio Medica Corp. | LDJ |
| Aug 5, 1999 | K991516 | MICRO-STRIP FOR MARIJUANA METABOLITES Microdiagnostics, Inc. | LDJ |
| Jul 7, 1999 | K990818 | RAPIDONE - MARIJUANA TEST American Bio Medica Corp. | LDJ |
| Apr 27, 1999 | K990870 | REDI-TEST THC Redwood Biotech, Inc. | LDJ |
| Dec 11, 1998 | K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS Roche Diagnostic Systems, Inc. | LDJ |
| Nov 18, 1998 | K983188 | DBEST TETRAHYDROCANNABINOL TEST KIT Ameritek, Inc. | LDJ |
| Jul 22, 1998 | K973154 | UBI MAGIWEL MARIJUANA METABOLITES United Biotech, Inc. | LDJ |
| Jun 29, 1998 | K980836 | GENIE CUP INTEGRATED SCREENING DEVICE Applied Technology Ventures, LLC | LDJ |
| May 28, 1998 | K981585 | ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) Roche Diagnostic Systems, Inc. | LDJ |
| May 28, 1998 | K981584 | ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) Roche Diagnostic Systems, Inc. | LDJ |
| Feb 13, 1998 | K973750 | STC CANNABINOIDS MICRO-PLATE EIA OraSure Technologies, Inc. | LDJ |
| Sep 25, 1997 | K973122 | QUICKSCREEN ONE STEP THC SCREENING TEST Phamatech | LDJ |
| Jul 3, 1997 | K970548 | ONE STEP MARIJUANA CARD TEST Teco Diagnostics | LDJ |
| Jun 25, 1997 | K971841 | BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST Bionike Laboratories, Inc. | LDJ |
| Apr 28, 1997 | K963916 | IMMULITE CANNABINOIDS Diagnostic Products Corp. | LDJ |
| Feb 28, 1997 | K963654 | QUIKSTRIP ONESTEP MARIJUANA (THC) TEST Syntron Bioresearch, Inc. | LDJ |
| Feb 20, 1997 | K963207 | QUICKPAC II ONE STEP MARIJUANA (THC) TEST Drial Consultants, Inc. | LDJ |
| Oct 30, 1996 | K963606 | VISUALINE COMBO V (COCAINE/THC) TEST Sun Biomedical Laboratories, Inc. | LDJ |
| Oct 30, 1996 | K963516 | VERDICT THC Editek, Inc. | LDJ |
| Aug 20, 1996 | K951853 | ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) Tcpi, Inc. | LDJ |
| Apr 3, 1996 | K955677 | SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT Beckman Instruments, Inc. | LDJ |
| Mar 6, 1996 | K954497 | FRONTLINE CANNABIS Boehringer Mannheim Corp. | LDJ |
| May 2, 1995 | K950445 | VISUALINE II CANNABINOIDS (THC) Sun Biomedical Laboratories, Inc. | LDJ |
| Apr 5, 1995 | K950181 | URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. | LDJ |
| Feb 22, 1995 | K945550 | ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC Princeton BioMeditech Corp. | LDJ |
| Feb 22, 1995 | K940158 | EMIT IIC CANNABINOID ASSAY Syva Co. | LDJ |
| Dec 29, 1994 | K944086 | CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS Beckman Instruments, Inc. | LDJ |
| Nov 21, 1994 | K944088 | CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS Beckman Instruments, Inc. | LDJ |
| Nov 4, 1994 | K943998 | CANNABINOID EIA ASSAY Diagnostic Reagents, Inc. | LDJ |
| Nov 2, 1994 | K944562 | MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION Microgenics Corp. | LDJ |
| Aug 1, 1994 | K942337 | CEDIA DAU MULTI-LEVEL THC ASSAY Microgenics Corp. | LDJ |
| Jun 2, 1994 | K940912 | USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500 U.S. Drug Testing, Inc. | LDJ |
| May 17, 1994 | K940649 | CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT Microgenics Corp. | LDJ |
| Jan 13, 1994 | K935591 | CEDIA DAU MULTI-LEVEL THC ASSAY Microgenics Corp. | LDJ |
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