Emit QST Procainamide Assay
FDA 510(k) K851061 · Syva Co.
510(k) numberK851061
Submission
- Device name
- Emit QST Procainamide Assay
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- March 15, 1985
- Decision date
- April 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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Questions and answers
When was Emit QST Procainamide Assay cleared by the FDA?
Emit QST Procainamide Assay (K851061) received a 510(k) decision of Substantially Equivalent on April 12, 1985, 28 days after the submission was received.
What is the product code of K851061?
The FDA product code is LAR – Enzyme Immunoassay, Procainamide, a Class II (moderate risk) device regulated under 21 CFR 862.3320.