Acs Cortisol Immunoassay
FDA 510(k) K962559 · Ciba Corning Diagnostics Corp.
510(k) numberK962559
Submission
- Device name
- Acs Cortisol Immunoassay
- Applicant
- Ciba Corning Diagnostics Corp.
Irvine, CA, US - Received
- July 1, 1996
- Decision date
- November 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFT – Fluorometric, Cortisol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1205
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242505 | Elecsys Cortisol IIIJFT · Traditional | Roche Diagnostics | 07/17/2025SE |
| K192788 | ADVIA Centaur Cortisol (COR)JFT · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/25/2019SE |
| K152227 | Elecsys Cortisol II, Cortisol II CalSetJFT · Traditional | Roche Diagnostics | 04/27/2016SE |
| K142723 | ADVIA Centaur Cortisol (COR) AssyJFT · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/31/2015SE |
| K062204 | Architect Cortisol AssayJFT · Traditional | Seradyn, Inc. | 09/22/2006SE |
| K033731 | Axsym Cortisol AssayJFT · Traditional | Fujirebio Diagnostics,Inc. | 02/20/2004SE |
| K021218 | Elecsys Cortisol Test SystemJFT · Traditional | Roche Diagnostics Corp. | 09/09/2002SE |
| K954591 | Aia-Pack Cort AssayJFT · Traditional | Tosoh Medics, Inc. | 12/15/1995SE |
| K934317 | Cidba Corning Acs Cortisol ImmunoassayJFT · Traditional | Ciba Corning Diagnostics Corp. | 05/13/1994SE |
| K931031 | Vidas Cortisol (Cort) Assay & Serum Free DilutentJFT · Traditional | Biomerieux Vitek, Inc. | 07/27/1993SE |
More from Biomerieux Vitek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963251 | Ciba Corning ACS;180 DPD AssayJMM · Traditional | 10/15/1996SE |
| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | 07/26/1996SE |
| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
| K962021 | Ciba Corning 348 SystemCHL · Traditional | 06/24/1996SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | 06/21/1996SE |
| 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 |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
| K954697 | Ciba Corning Acs ESTRADIOL-6 AssayCHP · Traditional | 12/13/1995SE |
Questions and answers
When was Acs Cortisol Immunoassay cleared by the FDA?
Acs Cortisol Immunoassay (K962559) received a 510(k) decision of Substantially Equivalent on November 5, 1996, 127 days after the submission was received.
What is the product code of K962559?
The FDA product code is JFT – Fluorometric, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.