Ciba Corning Acs FT4 Immunoassay
FDA 510(k) K910684 · Ciba Corning Diagnostics Corp.
510(k) numberK910684
Submission
- Device name
- Ciba Corning Acs FT4 Immunoassay
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- February 19, 1991
- Decision date
- May 1, 1991
- 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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| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
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Questions and answers
When was Ciba Corning Acs FT4 Immunoassay cleared by the FDA?
Ciba Corning Acs FT4 Immunoassay (K910684) received a 510(k) decision of Substantially Equivalent on May 1, 1991, 71 days after the submission was received.
What is the product code of K910684?
The FDA product code is CEC – Radioimmunoassay, Free Thyroxine, a Class II (moderate risk) device regulated under 21 CFR 862.1695.