Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229
FDA 510(k) K011620 · Syva Co., Dade Behring, Inc.
510(k) numberK011620
Submission
- Device name
- Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229
- Applicant
- Syva Co., Dade Behring, Inc.
San Jose, CA, US - Received
- May 25, 2001
- Decision date
- June 18, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K060738 | TDM N-AcetylprocainamideLAN · Traditional | Roche Diagnostics Corp. | 08/16/2006SE |
| K032564 | Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model DF111LAN · Traditional | Dade Behring, Inc. | 10/31/2003SE |
| 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 |
More from Roche Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011920 | Emit 2000 Digoxin Assay, Model OSR4H229KXT · Special | 07/02/2001SE |
| K011605 | Emit 2000 Quinidine Assay, Model OSR4Q229LBZ · Special | 06/12/2001SE |
| K011300 | Emit II Plus Cannabinoid Assay, Model OSR9N229LDJ · Special | 05/17/2001SE |
| K011306 | Emit II Plus Benzodiazepine Assay, Model 0SR9F229JXM · Special | 05/16/2001SE |
| K011289 | Emit II Plus Opiate Assay, Model OSR9B229DJG · Special | 05/15/2001SE |
| K011161 | Modification to the Emit II Plus Phencyclidine Assay, Model OSR9J229LCM · Special | 05/15/2001SE |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229KLS · Special | 05/10/2001SE |
| K011164 | Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229KXS · Special | 05/10/2001SE |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229JXN · Special | 05/10/2001SE |
| K011162 | Modification to the Emit II Plus Cocaine Metabolite AssayDIO · Special | 05/02/2001SE |
Questions and answers
When was Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229 cleared by the FDA?
Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229 (K011620) received a 510(k) decision of Substantially Equivalent on June 18, 2001, 24 days after the submission was received.
What is the product code of K011620?
The FDA product code is LAN – Enzyme Immunoassay, N-Acetylprocainamide, a Class II (moderate risk) device regulated under 21 CFR 862.3320.