Thermo Scientific Cedia Multi-Drug Oft Calibrators
FDA 510(k) K101752 · Microgenics Corp.
510(k) numberK101752
Submission
- Device name
- Thermo Scientific Cedia Multi-Drug Oft Calibrators
- Applicant
- Microgenics Corp.
Fremont Blvd., CA, US - Received
- June 22, 2010
- Decision date
- April 8, 2011
- 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
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| 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 |
| K051088 | Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsDKB · Traditional | Lin-Zhi International, Inc. | 06/24/2005SE |
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Questions and answers
When was Thermo Scientific Cedia Multi-Drug Oft Calibrators cleared by the FDA?
Thermo Scientific Cedia Multi-Drug Oft Calibrators (K101752) received a 510(k) decision of Substantially Equivalent on April 8, 2011, 290 days after the submission was received.
What is the product code of K101752?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.