Cedia Dau Negative Calibrator
FDA 510(k) K935793 · Microgenics Corp.
510(k) numberK935793
Submission
- Device name
- Cedia Dau Negative Calibrator
- Applicant
- Microgenics Corp.
Concord, CA, US - Received
- December 7, 1993
- Decision date
- March 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKB – Calibrators, Drug Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141928 | Cobas C Acetaminophen GEN.2 Assay, ACET2 CalibratorDKB · Traditional | Roche Diagnostics Operations (Rdo) | 11/25/2014SE |
| 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 |
| K090939 | Roche C.F.A.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical…DKB · Traditional | Roche Diagnostics | 06/18/2009SE |
| 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 |
| K062121 | Dimension Vista System Drug 2 Calibrator (Drug 2 Cal - KC420)DKB · Traditional | Dade Behring, Inc. | 08/25/2006SE |
| K060645 | Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus CalibratorsDKB · Abbreviated | Roche Diagnostics Corp. | 05/30/2006SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent KitJXM · Special | 12/11/2024SE |
| K240670 | DRI Ecstasy Plus AssayDKZ · Special | 10/30/2024SE |
| K231020 | Alinity c Tricyclic Antidepressants Reagent KitLFH · Traditional | 11/17/2023SE |
| K231007 | CEDIA Heroin Metabolite (6-AM) AssayDJG · Traditional | 09/27/2023SE |
| K213875 | DRI TM Tricyclics Serum Tox AssayLFH · Traditional | 12/21/2022SE |
| K211973 | DRI Cocaine Metabolite AssayDIO · Traditional | 09/24/2021SE |
| K192943 | CEDIA Heroin Metabolite (6-AM) assayDJG · Traditional | 12/16/2019SE |
| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | 12/09/2019SE |
| K181499 | DRI Cocaine Metabolite AssayDIO · Traditional | 07/06/2018SE |
| K173963 | DRI Benzodiazepine AssayJXM · Traditional | 02/21/2018SE |
Questions and answers
When was Cedia Dau Negative Calibrator cleared by the FDA?
Cedia Dau Negative Calibrator (K935793) received a 510(k) decision of Substantially Equivalent on March 14, 1994, 97 days after the submission was received.
What is the product code of K935793?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.