Stratus N-Acetylprocainamide Fluorometric Enzyme I
FDA 510(k) K853547 · American Dade
510(k) numberK853547
Submission
- Device name
- Stratus N-Acetylprocainamide Fluorometric Enzyme I
- Applicant
- American Dade
Santa Ana, CA, US - Received
- August 26, 1985
- Decision date
- September 16, 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 |
|---|---|---|
| K873051 | Stratus(R) HFSH Fluorometric Enzyme ImmunoassayCGJ · Traditional | 10/20/1987SE |
| K873171 | Stratus(R) Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 09/29/1987SE |
| K873052 | Stratus(R) HLH Fluorometric Enzyme ImmunoassayCEP · Traditional | 09/14/1987SE |
| K872789 | Paramax Urine/Csf CalibratorJIX · Traditional | 09/02/1987SE |
| K872195 | Data-Fi Dimertest Latex AssayDAP · Traditional | 08/06/1987SE |
| K872196 | Aqueous Blood Gas/Electrolyte Contr Lev I,Ii & IIIJJS · Traditional | 07/31/1987SE |
| K871972 | Stratus Ige Fluorometric Enzyme ImmunoassayDGE · Traditional | 07/21/1987SE |
| K871977 | Dade Moni-Trol Chemistry Control/CalibratorJJY · Traditional | 07/09/1987SE |
| K872050 | Paramax Cholesterol ReagentLBS · Traditional | 07/07/1987SE |
| K872360 | Data-Fi Fibrin(Ogen) Degradation Prod.(Fdp)Det SetGHH · Traditional | 07/06/1987SE |
Questions and answers
When was Stratus N-Acetylprocainamide Fluorometric Enzyme I cleared by the FDA?
Stratus N-Acetylprocainamide Fluorometric Enzyme I (K853547) received a 510(k) decision of Substantially Equivalent on September 16, 1985, 21 days after the submission was received.
What is the product code of K853547?
The FDA product code is LAN – Enzyme Immunoassay, N-Acetylprocainamide, a Class II (moderate risk) device regulated under 21 CFR 862.3320.