Stratus Free Thyroxine (FT4) Fluor. Enzyme Immuno.
FDA 510(k) K870158 · American Dade
510(k) numberK870158
Submission
- Device name
- Stratus Free Thyroxine (FT4) Fluor. Enzyme Immuno.
- Applicant
- American Dade
Santa Ana, CA, US - Received
- January 13, 1987
- Decision date
- March 19, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEC – Radioimmunoassay, Free Thyroxine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1695
- Specialty
- Clinical Chemistry
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More from Roche Diagnostics
| 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 Free Thyroxine (FT4) Fluor. Enzyme Immuno. cleared by the FDA?
Stratus Free Thyroxine (FT4) Fluor. Enzyme Immuno. (K870158) received a 510(k) decision of Substantially Equivalent on March 19, 1987, 65 days after the submission was received.
What is the product code of K870158?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.