Abuscreen(R) Online Calibrators
FDA 510(k) K905828 · Roche Diagnostic Systems, Inc.
510(k) numberK905828
Submission
- Device name
- Abuscreen(R) Online Calibrators
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- December 18, 1990
- Decision date
- February 4, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DKB – Calibrators, Drug Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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| K133710 | Lzi Multiple Analyte Set A;B;C Drugs of Abuse ControlsDKB · Traditional | Lin-Zhi International, Inc. | 02/21/2014SE |
| K120936 | Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent…DKB · Abbreviated | Microgenics Corporation | 12/13/2012SE |
| K092266 | Randox Methamphetamine AssayDKB · Traditional | Randox Laboratories, Ltd. | 05/09/2011SE |
| K101752 | Thermo Scientific Cedia Multi-Drug Oft CalibratorsDKB · Traditional | Microgenics Corp. | 04/08/2011SE |
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| K090900 | Advia Chemistry Drug Calibrator II, Model 10376771DKB · Abbreviated | Siemens Healthcare Diagnostics | 06/01/2009SE |
| K062162 | Dimension Vista System Drugs of Abuse Calibrator (Udat Cal - KC510)DKB · Traditional | Dade Behring, Inc. | 09/14/2006SE |
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More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Abuscreen(R) Online Calibrators cleared by the FDA?
Abuscreen(R) Online Calibrators (K905828) received a 510(k) decision of Substantially Equivalent on February 4, 1991, 48 days after the submission was received.
What is the product code of K905828?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.