Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110
FDA 510(k) K032573 · Dade Behring, Inc.
510(k) numberK032573
Submission
- Device name
- Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110
- Applicant
- Dade Behring, Inc.
P.O. Box 6101, Newark, DE, US - Received
- August 20, 2003
- Decision date
- October 31, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAR – Enzyme Immunoassay, Procainamide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LAR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060773 | Online TDM ProcainamideLAR · Traditional | Roche Diagnostics Corp. | 08/23/2006SE |
| K010812 | Emit 2000 Procainamide Assay, Model OSR4K229LAR · Special | Syva Co., Dade Behring, Inc. | 04/13/2001SE |
| K971716 | Procainamide Assay for the Bayer Immuno 1 SystemLAR · Traditional | Bayer Corp. | 06/27/1997SE |
| K963306 | Cedia N-Acetylprocainamide AssayLAR · Traditional | Boehringer Mannheim Corp. | 10/29/1996SE |
| K962099 | Cedia Procainamide AssayLAR · Traditional | Boehringer Mannheim Corp. | 08/27/1996SE |
| K962463 | Procainamide Enzyme ImmunoassayLAR · Traditional | Diagnostic Reagents, Inc. | 08/14/1996SE |
| K955444 | Abbott Axsm Procainamide AssayLAR · Traditional | Abbott Laboratories | 04/02/1996SE |
| K951434 | Opus ProcainamideLAR · Traditional | Behring Diagnostics, Inc. | 07/03/1995SE |
| K942847 | Cobas(R)-Fp Reagent for Procainamide/CalibratorLAR · Traditional | Roche Diagnostic Systems, Inc. | 12/02/1994SE |
| K934762 | Opus Procainamide Test SystemLAR · Traditional | Pb Diagnostic Systems, Inc. | 07/20/1994SE |
More from Pb Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K093848 | Pt-Multi-Calibrator, Model OPAT07GGN · Traditional | 12/20/2010SE |
| K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…CFN · Traditional | 07/28/2008SE |
| K081249 | Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…DEB · Traditional | 07/21/2008SE |
| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)DHX · Traditional | 06/25/2008SE |
| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | 06/04/2008SE |
| K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…CEC · Traditional | 03/13/2008SE |
| K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…CFN · Traditional | 02/26/2008SE |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional | 02/21/2008SE |
| K073055 | Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270JFY · Traditional | 01/03/2008SE |
| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional | 12/21/2007SE |
Questions and answers
When was Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110 cleared by the FDA?
Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110 (K032573) received a 510(k) decision of Substantially Equivalent on October 31, 2003, 72 days after the submission was received.
What is the product code of K032573?
The FDA product code is LAR – Enzyme Immunoassay, Procainamide, a Class II (moderate risk) device regulated under 21 CFR 862.3320.