510(k) K080183
- Device
- CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K080183
- Product code
- DIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-25
- Date received
- 2008-01-25
- Regulation
- 862.3280
- Classification name
- Drug Mixture Control Materials
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DIMITRIS DEMIRTZOGLOU
- Address
- 9115 Hague Rd. Bx 50416 Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 1032263
- 3001431095
- 3010939897
- 2030861
- 2432495
- 2517506
- 3004175381
- 3010127294
- 3005333358
- 3006198300
- 3004493545
- 1319808
- 3000308930
- 1649661
- 2060833
- 1616487
- 3002809144
- 2319772
- 1220649
- 3002642396
- 3013982035
- 3008156187
- 3003593973
- 9610126
- 2020952
- 3003795116
- 2022375
- 3012963943
- 1827821
- 2250051
- 1932270
- 2050012
- 9610529
- 1050155
- 3003610499
- 2016706
- 2050010
- 2030633
- 3014607865
- 2432235
- 1319681
Source Documents#
Other 510(k) Records For Product Code DIF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153474 | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series | Biochemical Diagnostics, Inc. | 2016-02-23 |
| K132688 | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ | Biochemical Diagnostics, Inc. | 2013-12-16 |
| K132174 | MULTICHEM WBT | Techno-Path Manufacturing , Ltd. | 2013-09-20 |
| K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | Biochemical Diagnostic, Inc. | 2012-07-03 |
| K121143 | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | Bio-Rad Laboratories | 2012-05-18 |
| K120504 | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK | Bio-Rad Laboratories, Inc. | 2012-03-27 |
| K103656 | THERMO SCIENTIFIC MAS R DOA TOTAL | Microgenics Corporation | 2011-03-24 |
| K093577 | LIQUICHEK OPIATE CONTROL | Bio-Rad Laboratories | 2010-03-12 |
| K080085 | MAS TOX CONTROL | Thermo Fisher Scientific | 2008-04-30 |
| K072721 | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC | Bio-Rad, Diagnostics Grp. | 2007-12-11 |
| K063398 | ESA LEADCARE II LEAD CONTROL | Bionostics, Inc. | 2006-12-05 |
| K062191 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 | Dade Behring, Inc. | 2006-08-21 |
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | Biosite Incorporated | 2006-07-10 |
| K060417 | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | Quantimetrix Corp. | 2006-03-21 |
| K052053 | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK | Bio-Rad | 2005-08-09 |
Legacy Summary#
summary
FDA Review#
Decision Summary