Delfia(Tm) Cortisol Kit
FDA 510(k) K863422 · Lkb Instruments, Inc.
510(k) numberK863422
Submission
- Device name
- Delfia(Tm) Cortisol Kit
- Applicant
- Lkb Instruments, Inc.
Gaithersburg, MD, US - Received
- September 4, 1986
- Decision date
- September 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K962559 | Acs Cortisol ImmunoassayJFT · Traditional | Ciba Corning Diagnostics Corp. | 11/05/1996SE |
| 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 |
More from Ciba Corning Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K874094 | 1205 Betaplate Liquid Scintillation CounterJJJ · Traditional | 11/04/1987SE |
| K872955 | Delfia(Tm) Ferritin KitJMG · Traditional | 08/21/1987SE |
| K871303 | Delfia(Tm) Thyroxine (T4) KitCDX · Traditional | 06/17/1987SE |
| K871599 | Delfia(Tm) Hige KitDHB · Traditional | 06/12/1987SE |
| K871644 | Delfia (TM) HTSH KitJLW · Traditional | 05/12/1987SE |
| K864452 | Delfia(Tm) Triiodothyronine (T3) KitCDP · Traditional | 02/02/1987SE |
| K864733 | LKB 2260 MacrotomeIDO · Traditional | 01/05/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | 12/18/1986SE |
| K862044 | Delfia (TM) HCG KitJHJ · Traditional | 07/11/1986SE |
| K861195 | Delfia DigoxinKXT · Traditional | 07/11/1986SE |
Questions and answers
When was Delfia(Tm) Cortisol Kit cleared by the FDA?
Delfia(Tm) Cortisol Kit (K863422) received a 510(k) decision of Substantially Equivalent on September 26, 1986, 22 days after the submission was received.
What is the product code of K863422?
The FDA product code is JFT – Fluorometric, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.