Opus Procainamide Test System
FDA 510(k) K934762 · Pb Diagnostic Systems, Inc.
510(k) numberK934762
Submission
- Device name
- Opus Procainamide Test System
- Applicant
- Pb Diagnostic Systems, Inc.
Westwood, MA, US - Received
- October 4, 1993
- Decision date
- July 20, 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 |
| K942847 | Cobas(R)-Fp Reagent for Procainamide/CalibratorLAR · Traditional | Roche Diagnostic Systems, Inc. | 12/02/1994SE |
More from Roche Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940507 | Opus FT4 Test SystemCEC · Traditional | 07/28/1994SE |
| K933389 | Opus Cmv-GLFZ · Traditional | 06/28/1994SE |
| K934137 | Opus(R) Serology Controls, ModificationMJX · Traditional | 03/07/1994SE |
| K935229 | Opus DigitoxinDPG · Traditional | 12/22/1993SE |
| K934705 | Opus NapaLAN · Traditional | 11/22/1993SE |
| K933675 | Opus Total CKCGS · Traditional | 09/08/1993SE |
| K933066 | Opus EstradiolCHP · Traditional | 09/08/1993SE |
| K932279 | Opus(R) Total B-Hcg Test SystemJHI · Traditional | 07/08/1993SE |
| K926131 | Opus Magnum AnalyzerKHO · Traditional | 06/07/1993SE |
| K924957 | Opus(R) VancomycinLEH · Traditional | 12/11/1992SE |
Questions and answers
When was Opus Procainamide Test System cleared by the FDA?
Opus Procainamide Test System (K934762) received a 510(k) decision of Substantially Equivalent on July 20, 1994, 289 days after the submission was received.
What is the product code of K934762?
The FDA product code is LAR – Enzyme Immunoassay, Procainamide, a Class II (moderate risk) device regulated under 21 CFR 862.3320.