Liqui-Sera TDM Calibrators
FDA 510(k) K834398 · Biodiagnostic Intl
510(k) numberK834398
Submission
- Device name
- Liqui-Sera TDM Calibrators
- Applicant
- Biodiagnostic Intl
Mchenry, IL, US - Received
- December 14, 1983
- Decision date
- February 3, 1984
- 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
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 |
|---|---|---|
| K031296 | Liqui-Heme Glyco A1C AssayLCP · Traditional | 10/15/2004SE |
| K881430 | Liqui-Sera Serum Alcohol ControlsJJX · Traditional | 07/08/1988SE |
| K874459 | Liqui-Sera Spinal Fluid ControlJJY · Traditional | 12/29/1987SE |
| K863849 | Liqui-Sera Combo Ligand/Tdm ControlsJJY · Traditional | 11/24/1986SE |
| K853906 | Liqui-Sera Chemistry Controls (Comprehensive)JJY · Traditional | 10/04/1985SE |
| K853887 | Liqui-Sera Chem. Multiple CalibratorsJIT · Traditional | 09/30/1985SE |
| K842668 | Liqui-Heme Hemoglobin CalibratorsKRZ · Traditional | 03/05/1985SE |
| K840618 | Liqui-Ura Chemistry Urine ControlsJJW · Traditional | 04/04/1984SE |
| K834259 | Liqui-Ura Toxic Urine ControlDIF · Traditional | 01/30/1984SE |
| K831278 | Liqui-Sera Anticonvulsants ControlsDIF · Traditional | 05/27/1983SE |
Questions and answers
When was Liqui-Sera TDM Calibrators cleared by the FDA?
Liqui-Sera TDM Calibrators (K834398) received a 510(k) decision of Substantially Equivalent on February 3, 1984, 51 days after the submission was received.
What is the product code of K834398?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.