Product code DKB— Clinical Toxicology
DRUG CALIBRATOR II
- Classification name
- Calibrators, Drug Mixture
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Total cleared
- 94
- First cleared
- Most recent
Market context for product code DKB
FDA has cleared devices under product code DKB between 1979 and 2014, filed by 33 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2014
- 2012
- 2011
- 2009
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
Top applicants under product code DKB
Recent clearances under product code DKB
- K141928 — COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR
- K133710 — LZI MULTIPLE ANALYTE SET A; B; C DRUGS OF ABUSE CONTROLS
- K120936 — ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
- K092266 — RANDOX METHAMPHETAMINE ASSAY
- K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
- K090939 — ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
- K090900 — ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
- K062162 — DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
- K062121 — DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
- K060645 — PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
- K051088 — MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
- K033879 — VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
- K033306 — PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
- K032574 — DIMENSION DRUG CALIBRATOR II, MODEL DC49C
- K031856 — PRECISET TDM I AND PRECISET TDM II CALIBRATORS
- K031775 — PRECISET DAT PLUS I CALIBRATORS
- K021393 — PRECISET DAT PLUS
- K013959 — BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
- K012318 — RANDOX THERAPEUTIC DRUG CALIBRATOR
- K993954 — SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
- K993755 — EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
- K990255 — DIMENSION DRUG CALIBRATOR II, MODEL DC49B
- K983747 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
- K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
- K983209 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
- K982871 — DRUG CALIBRATOR II
- K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
- K980853 — CEDIA DAU MULTI-DRUG CALIBRATORS
- K974699 — REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
- K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
- K971287 — SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
- K962817 — DRUG CALIBRATOR II
- K963191 — CEDIA ANTIBIOTIC TDM MULTI-CALS
- K961273 — AED CALIBRATORS
- K961372 — SERUM TOX CALIBRATOR
- K954608 — CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
- K935192 — EMIT IIC CALIBRATORS
- K950139 — DRUGS OF ABUSE CALIBRATOR
- K945289 — DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
- K942048 — ROCHE AMMONIA (VARIOUS)
- K940935 — URINE CALIBRATOR
- K935793 — CEDIA DAU NEGATIVE CALIBRATOR
- K936028 — CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
- K935101 — URINE CALIBRATORS AND CONTROLS MODIFICATION
- K935792 — CEDIA DAU 5-DRUG CALIBRATORS
- K935794 — CEDIA DAU 4-DRUG CUTOFF CALIBRATOR
- K935550 — ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
- K931124 — ABUSCREEN ONLINE(R) CALIBRATORS
- K932753 — ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
- K932754 — ABUSCREEN CALIBRATION STANDARD
- K923340 — ROCHE ABUSCREEN ONLINNE CALIBRATORS
- K920208 — URINE A CALIBRATOR
- K915003 — EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
- K913740 — IL TEST(TM) DAT CAL/CONTROL SET B
- K913741 — IL TEST(TM) DAT CAL/CONTROL SET C
- K910881 — CONTROL AND LINEARITY
- K913739 — IL TEST(TM) DAT CALIBRATOR A( -)
- K913335 — ABUSCREEN(R) ONLINE(TM) CALIBRATORS
- K912729 — EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
- K910085 — ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
- K905828 — ABUSCREEN(R) ONLINE CALIBRATORS
- K910087 — ABUSCREEN ONLINE OPIATES CALIBRATORS
- K904764 — EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)
- K903152 — EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS
- K902581 — EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
- K902578 — EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2
- K901573 — EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B
- K894934 — HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS
- K893815 — HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS
- K892332 — DRUGS OF ABUSE URINE CALIBRATORS
- K884177 — DRUG STANDARD SET
- K881320 — URINE TOXICOLOGY STANDARD
- K881943 — EMIT HVA CALIBRATOR KIT
- K875216 — HIGH PERFORMANCE CALIBRATORS
- K880705 — THERAPEUTIC DRUG STANDARD
- K872392 — ACA URINE DRUGS OF ABUSE CALIBRATOR
- K871174 — 4-9295 BARBITURATES TEST MIX
- K862403 — EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95
- K843507 — EMIT 700 CALIBRATOR B
- K843163 — EMIT 700 CALIBRATOR A
- K842816 — EMIT D.A.U. LOW & MED. CALIBRATORS B
- K842386 — ACA BARBITURATES SCREEN/BENZODIAZEPIN
- K834398 — LIQUI-SERA TDM CALIBRATORS
- K833761 — THERAPEUTIC DRUG CONTROL
- K833276 — DRUG STANDARDS
- K823740 — ADVANCE SYSTEM EMITAED ANTIEPILEPTIC
- K821767 — EMIT ST URINE METHAGUALONE CALIBRATOR
- K820461 — EMIT-ST URINE CALIBRATOR A (#3A319
- K820190 — CALIBRATOR SET
- K811674 — DRUG STANDARDS
- K811620 — EMIT-TOX SERUM CALIBRATORS
- K810464 — EMIT-ST SERUM CALBRATOR
- K802624 — EMIT-STM URINE CALIBRATORS
- K790735 — EMIT-TOX SERUM CALIBRATORS
Data sourced from openFDA. This site is unofficial and independent of the FDA.