Online TDM Procainamide
FDA 510(k) K060773 · Roche Diagnostics Corp.
510(k) numberK060773
Submission
- Device name
- Online TDM Procainamide
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- March 22, 2006
- Decision date
- August 23, 2006
- 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 |
|---|---|---|---|
| K032573 | Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110LAR · Traditional | Dade Behring, Inc. | 10/31/2003SE |
| 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 |
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Questions and answers
When was Online TDM Procainamide cleared by the FDA?
Online TDM Procainamide (K060773) received a 510(k) decision of Substantially Equivalent on August 23, 2006, 154 days after the submission was received.
What is the product code of K060773?
The FDA product code is LAR – Enzyme Immunoassay, Procainamide, a Class II (moderate risk) device regulated under 21 CFR 862.3320.