510(k) K031856
- Device
- PRECISET TDM I AND PRECISET TDM II CALIBRATORS
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K031856
- Product code
- DKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-08-06
- Date received
- 2003-06-16
- Regulation
- 862.3200
- Classification name
- Calibrators, Drug Mixture
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KERWIN KAUFMAN
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 2020952
- 3006198300
- 3003795116
- 2030861
- 2050012
- 3005333358
- 2432235
- 9610529
- 3012963943
- 2250051
- 1319808
- 3010939897
- 3002809144
- 2517506
- 1827821
- 3004493545
- 3033967997
- 3002642396
- 1226774
- 2050010
- 8020888
- 1616487
- 1219913
- 9610126
- 1319681
- 3003610499
- 3000308930
- 3017181603
- 3003593973
Source Documents#
Other 510(k) Records For Product Code DKB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K141928 | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | Roche Diagnostics Operations (Rdo) | 2014-11-25 |
| K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | Lin-Zhi International, Inc. | 2014-02-21 |
| K120936 | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS | Microgenics Corporation | 2012-12-13 |
| K092266 | RANDOX METHAMPHETAMINE ASSAY | Randox Laboratories, Ltd. | 2011-05-09 |
| K101752 | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | Microgenics Corp. | 2011-04-08 |
| K090939 | ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 | Roche Diagnostics | 2009-06-18 |
| K090900 | ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 | Siemens Healthcare Diagnostics | 2009-06-01 |
| K062162 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) | Dade Behring, Inc. | 2006-09-14 |
| K062121 | DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) | Dade Behring, Inc. | 2006-08-25 |
| K060645 | PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | Roche Diagnostics Corp. | 2006-05-30 |
| K051088 | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2005-06-24 |
| K033879 | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 | Maine Standards Co. | 2004-02-27 |
| K033306 | PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | Roche Diagnostics Corp. | 2003-12-15 |
| K032574 | DIMENSION DRUG CALIBRATOR II, MODEL DC49C | Dade Behring, Inc. | 2003-10-06 |
| K031775 | PRECISET DAT PLUS I CALIBRATORS | Roche Diagnostics Corp. | 2003-08-05 |
Legacy Summary#
summary
FDA Review#
Decision Summary