Emit QST N-Acetylprocainamide Assay
FDA 510(k) K851060 · Syva Co.
510(k) numberK851060
Submission
- Device name
- Emit QST N-Acetylprocainamide Assay
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- March 15, 1985
- Decision date
- April 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Em Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
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| K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional | 08/13/2001SE |
| K012257 | Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229DKZ · Special | 08/03/2001SE |
| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | 06/06/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | 05/17/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Emit QST N-Acetylprocainamide Assay cleared by the FDA?
Emit QST N-Acetylprocainamide Assay (K851060) received a 510(k) decision of Substantially Equivalent on April 5, 1985, 21 days after the submission was received.
What is the product code of K851060?
The FDA product code is LAN – Enzyme Immunoassay, N-Acetylprocainamide, a Class II (moderate risk) device regulated under 21 CFR 862.3320.