Cobas(R)-Fp Reagent for Procainamide/Calibrator
FDA 510(k) K942847 · Roche Diagnostic Systems, Inc.
510(k) numberK942847
Submission
- Device name
- Cobas(R)-Fp Reagent for Procainamide/Calibrator
- Applicant
- Roche Diagnostic Systems, Inc.
Branchburg, NJ, US - Received
- June 16, 1994
- Decision date
- December 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K934762 | Opus Procainamide Test SystemLAR · Traditional | Pb Diagnostic Systems, Inc. | 07/20/1994SE |
More from Pb Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Cobas(R)-Fp Reagent for Procainamide/Calibrator cleared by the FDA?
Cobas(R)-Fp Reagent for Procainamide/Calibrator (K942847) received a 510(k) decision of Substantially Equivalent on December 2, 1994, 169 days after the submission was received.
What is the product code of K942847?
The FDA product code is LAR – Enzyme Immunoassay, Procainamide, a Class II (moderate risk) device regulated under 21 CFR 862.3320.