DRUGS OF ABUSE CALIBRATOR
FDA 510(k) clearance K950139 · decided 1995-02-22
Clearance details
- K-number
- K950139
- Device name
- DRUGS OF ABUSE CALIBRATOR
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-13
- Decision date
- 1995-02-22
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- DKB
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR (K141928) | Roche Diagnostics Operations (Rdo) | 2014-11-25 |
| LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS (K133710) | Lin-Zhi International, Inc. | 2014-02-21 |
| ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS (K120936) | Microgenics Corporation | 2012-12-13 |
| RANDOX METHAMPHETAMINE ASSAY (K092266) | Randox Laboratories, Ltd. | 2011-05-09 |
| THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (K101752) | Microgenics Corp. | 2011-04-08 |
| ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 (K090939) | Roche Diagnostics | 2009-06-18 |
| ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 (K090900) | Siemens Healthcare Diagnostics | 2009-06-01 |
| DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) (K062162) | Dade Behring, Inc. | 2006-09-14 |
| DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) (K062121) | Dade Behring, Inc. | 2006-08-25 |
| PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS (K060645) | Roche Diagnostics Corp. | 2006-05-30 |
| MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS (K051088) | Lin-Zhi International, Inc. | 2005-06-24 |
| VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 (K033879) | Maine Standards Co. | 2004-02-27 |
Recalls involving this device
No recalls on record reference this clearance.