Stratus Primidone Florometric Enzy
FDA 510(k) K842196 · American Dade
510(k) numberK842196
Submission
- Device name
- Stratus Primidone Florometric Enzy
- Applicant
- American Dade
Mchenry, IL, US - Received
- June 4, 1984
- Decision date
- July 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFT – Fluorescent Immunoassay, Primidone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3680
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950028 | Primidone Fpia Reagent Set and CalibratorsLFT · Traditional | Sigma Diagnostics, Inc. | 03/21/1995SE |
| K904683 | Stratus Primidone Fluorometric EnzymeLFT · Traditional | Baxter Healthcare Corp | 11/28/1990SE |
| K895567 | Primidone (Fpia) KitLFT · Traditional | Tudor Laboratories, Inc. | 10/20/1989SE |
| K852318 | Cobas FP Reagen for Primidone & Primi CalibratorsLFT · Traditional | Roche Diagnostic Systems, Inc. | 06/25/1985SE |
| K823741 | Advance Emit-Aed Primedone AssayLFT · Traditional | Syva Co. | 01/07/1983SE |
| K822229 | Primidone Fluorescent ImmunoassayLFT · Traditional | American Diagnostic Corp. | 08/12/1982SE |
| K811007 | Ames Tda TM Primidone TestLFT · Traditional | Miles Laboratories, Inc. | 04/29/1981SE |
More from Miles Laboratories, 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 Primidone Florometric Enzy cleared by the FDA?
Stratus Primidone Florometric Enzy (K842196) received a 510(k) decision of Substantially Equivalent on July 11, 1984, 37 days after the submission was received.
What is the product code of K842196?
The FDA product code is LFT – Fluorescent Immunoassay, Primidone, a Class II (moderate risk) device regulated under 21 CFR 862.3680.