4-9295 Barbiturates Test Mix
FDA 510(k) K871174 · Supelco, Inc.
510(k) numberK871174
Submission
- Device name
- 4-9295 Barbiturates Test Mix
- Applicant
- Supelco, Inc.
Bellefonte, PA, US - Received
- March 24, 1987
- Decision date
- June 11, 1987
- 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 |
|---|---|---|
| K894141 | Liquid Chromatography ColumnsDPM · Traditional | 08/21/1989SE |
| K884403 | Liquid Chromatography Columns Solid Phase Ex. TubeDPM · Traditional | 12/22/1988SE |
| K883615 | Liquid Chromatography Columns 5-7070/71/72/73DJY · Traditional | 12/16/1988SE |
| K881868 | Liquid Chromatography Columns Hisep Column & GuardDPM · Traditional | 08/29/1988SE |
| K881361 | Solid Phase Extraction TubesDJY · Traditional | 08/08/1988SE |
| K880724 | Liquid Chromato. ColumnsDPM · Traditional | 05/27/1988SE |
| K874824 | Capillary Columns for Gas ChromatographyDII · Traditional | 01/21/1988SE |
| K862542 | Capillary Columns for Gas ChromatographyDII · Traditional | 08/04/1986SE |
| K862541 | Liquid Chromatography ColumnsDPM · Traditional | 07/29/1986SE |
| K861633 | Liquid Chromatography ColumnsDPM · Traditional | 05/23/1986SE |
Questions and answers
When was 4-9295 Barbiturates Test Mix cleared by the FDA?
4-9295 Barbiturates Test Mix (K871174) received a 510(k) decision of Substantially Equivalent on June 11, 1987, 79 days after the submission was received.
What is the product code of K871174?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.