Product code DLJ
- Device name
- Calibrators, Drug Specific
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3200
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132090 | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 | Randox Laboratories, Ltd. | 2013-08-08 |
| K091617 | QMS LIDOCAINE CALIBRATORS, MODEL 0374678 | Thermo Fisher Scientific | 2009-07-17 |
| K082030 | DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 | Siemens Healthcare Diagnostics, Inc. | 2008-08-22 |
| K062182 | DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 | Dade Behring, Inc. | 2006-09-14 |
| K062199 | DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) | Dade Behring, Inc. | 2006-09-06 |
| K061503 | DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) | Dade Behring, Inc. | 2006-06-22 |
| K060503 | DIMENSION TACR CALIBRATOR, MODEL DC107 | Dade Behring, Inc. | 2006-05-18 |
| K053108 | DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 | Dade Behring, Inc. | 2006-02-16 |
| K052015 | DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 | Dade Behring, Inc. | 2005-09-12 |
| K033601 | LABONE MICRO-PLATE COTININE EIA | Labone, Inc. | 2004-02-10 |
| K033246 | PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS | Roche Diagnostics Corp. | 2003-12-02 |
| K033165 | PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS | Roche Diagnostics Corp. | 2003-10-14 |
| K023780 | DRI PRIMIDONE CALIBRATORS | Microgenics Corp. | 2003-02-10 |
| K023316 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2002-12-16 |
| K021449 | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2002-06-18 |
| K020845 | EMIT 2000 VANCOMYCIN CALIBRATORS | Dade Behring, Inc. | 2002-05-08 |
| K020769 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2002-04-03 |
| K012109 | DRI ECSTASY URINE CALIBRATORS | Microgenics Corp. | 2001-08-27 |
| K011112 | CYCLOSPORINE CALIBRATOR | Dade Behring, Inc. | 2001-07-17 |
| K993473 | SYNCHRON SYSTEMS DRUG CALIBRATOR 2 | Beckman Coulter, Inc. | 1999-11-26 |
| K993022 | SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS | Beckman Coulter, Inc. | 1999-11-09 |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | Roche Diagnostic Systems, Inc. | 1998-12-15 |
| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | Roche Diagnostic Systems, Inc. | 1998-12-15 |
| K981926 | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | 1998-07-22 |
| K973536 | ACE PHENOBARBITAL REAGENT/AED CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-06 |
| K972835 | 50NG/ML COCAINE METABOLITE CALIBRATOR | Diagnostic Reagents, Inc. | 1997-08-28 |
| K972433 | CEDIA DIGOXIN CALIBRATORS | Boehringer Mannheim Corp. | 1997-07-24 |
| K970509 | INNOFLOUR CALIBRATOR REAGENT SET | Oxis Intl., Inc. | 1997-05-12 |
| K962280 | ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR | Roche Diagnostic Systems, Inc. | 1996-08-16 |
| K961726 | ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 | Roche Diagnostic Systems, Inc. | 1996-07-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414027944 | Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 | Siemens Healthcare Diagnostics Inc. | 2018-06-09 |
| 00630414027951 | Emit II Plus Specialty Multi Drug Calibrator/Control Level 3 | Siemens Healthcare Diagnostics Inc. | 2018-06-09 |
| 00630414027968 | Emit II Plus Specialty Multi Drug Calibrator/Control Level 2 | Siemens Healthcare Diagnostics Inc. | 2018-06-09 |
| 00630414028026 | Emit II Plus Specialty Multi Drug Calibrator/Control Level 1 | Siemens Healthcare Diagnostics Inc. | 2018-06-09 |
| 00630414601168 | Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 4 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414601144 | Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 2 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414601151 | Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 3 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00380740001742 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740001735 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00817302021097 | CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT. KIT ST417 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020830 | CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT ST324 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020854 | CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT BL-424 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020861 | CAROLINA LIQUID CHEMISTRIES CORP.® BUP REAGENT KIT Product No. DT424 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302021011 | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT MR425 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302021080 | CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT. KIT MR417 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| B076S0000B1 | LZI Oral Fluid Collectors | LIN-ZHI INTERNATIONAL, INC. | 2016-07-07 |
| B0760076C0 | Cannabinoids DAU Calibrator/Control, Calibrator/Control | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| B076S02920 | Oral Fluid 6-Acetylmorphine Calibrator/Control, Low Calibrator/Level 1 Control | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| B07601440 | Barbiturate DAU Calibrator/Control, Calibrator #4/Cutoff B/Control 3 | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| B07601430 | Barbiturate DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2 | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| B07601420 | Barbiturate DAU Calibrator/Control, Calibrator #2/Control 1 | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| B07601340 | Benzodiazepine DAU Calibrator/Control, Calibrator #4/Cutoff B/Control 3 | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| B07601330 | Benzodiazepine DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2 | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| B07601320 | Benzodiazepine DAU Calibrator/Control, Calibrator #2/Control 1 | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| B0760007C0 | Cannabinoids DAU Calibrator/Control, Calibrator/Control | LIN-ZHI INTERNATIONAL, INC. | 2016-07-05 |
| 00380740001810 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740001766 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740001759 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740001711 | ARCHITECT | Abbott GmbH | 2016-06-06 |
| 00380740001308 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |