High Performance Calibrators
FDA 510(k) K875216 · Rapid Diagnostic Laboratories, Inc.
510(k) numberK875216
Submission
- Device name
- High Performance Calibrators
- Applicant
- Rapid Diagnostic Laboratories, Inc.
Port Washington, NY, US - Received
- December 22, 1987
- Decision date
- June 22, 1988
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K903909 | Blind Controls for Drugs of Abuse TestingDIF · Traditional | 10/26/1990SE |
| K890030 | New Low Level Drug Mixture ControlDIF · Traditional | 01/23/1989SE |
| K871694 | Hyperformance Controls (Hp-Controls)DIF · Traditional | 07/07/1987SE |
| K863117 | High Performance Cannabinoid ControlsLAS · Traditional | 09/25/1986SE |
| K850139 | Cobe Cop Filter Cardiopulmonary Prebypass FilterKRJ · Traditional | 04/10/1985SE |
Questions and answers
When was High Performance Calibrators cleared by the FDA?
High Performance Calibrators (K875216) received a 510(k) decision of Substantially Equivalent on June 22, 1988, 183 days after the submission was received.
What is the product code of K875216?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.