TDM N-Acetylprocainamide
FDA 510(k) K060738 · Roche Diagnostics Corp.
510(k) numberK060738
Submission
- Device name
- TDM N-Acetylprocainamide
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- March 20, 2006
- Decision date
- August 16, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAN – Enzyme Immunoassay, N-Acetylprocainamide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LAN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032564 | Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model DF111LAN · Traditional | Dade Behring, Inc. | 10/31/2003SE |
| K011620 | Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229LAN · Special | Syva Co., Dade Behring, Inc. | 06/18/2001SE |
| K983812 | Napa Eia AssayLAN · Traditional | Diagnostic Reagents, Inc. | 11/16/1998SE |
| K971713 | N-Acetylprocainamide Assay for the Bayer Immuno 1 SystemLAN · Traditional | Bayer Corp. | 06/11/1997SE |
| K955422 | Axsym N-AcetylprocainamideLAN · Traditional | Abbott Laboratories | 04/24/1996SE |
| K934705 | Opus NapaLAN · Traditional | Pb Diagnostic Systems, Inc. | 11/22/1993SE |
| K922915 | Emit 2000 N-Acetylprocainamide Assay and CalibratLAN · Traditional | Syva Co. | 08/24/1992SE |
| K895571 | N-Acetylprocainamide (Napa) (Fpia) KitLAN · Traditional | Tudor Laboratories, Inc. | 10/25/1989SE |
| K873349 | Easy-Test Emit N-Acetylprocainamide Napa #16649LAN · Traditional | Em Diagnostic Systems, Inc. | 09/22/1987SE |
| K871680 | Modified Cobas FP Reagents for Napa and CalibratorLAN · Traditional | Roche Diagnostic Systems, Inc. | 06/08/1987SE |
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Questions and answers
When was TDM N-Acetylprocainamide cleared by the FDA?
TDM N-Acetylprocainamide (K060738) received a 510(k) decision of Substantially Equivalent on August 16, 2006, 149 days after the submission was received.
What is the product code of K060738?
The FDA product code is LAN – Enzyme Immunoassay, N-Acetylprocainamide, a Class II (moderate risk) device regulated under 21 CFR 862.3320.