NDS Cortisol Test Kit and NDS Cortisol Calibrator
FDA 510(k) K900010 · Kallestad Diag, A Div. of Erbamont, Inc.
510(k) numberK900010
Submission
- Device name
- NDS Cortisol Test Kit and NDS Cortisol Calibrator
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
Chaska, MN, US - Received
- January 2, 1990
- Decision date
- April 3, 1990
- 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 |
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| K910885 | QM300 Calibrator G PackGTQ · Traditional | 06/17/1991SE |
| K904725 | Chlamydia System Software (CSS)LJC · Traditional | 01/14/1991SE |
| K902253 | Pathfinder(Tm) Chlamydia Microplate KitLJC · Traditional | 07/26/1990SE |
| K902462 | Modified QM300 Rheumatoid Factor TestDHR · Traditional | 06/21/1990SE |
| K900009 | NDS Theophylline Test Kit & NDS TDM Calibrator SetKLS · Traditional | 03/29/1990SE |
| K897072 | NDS Thyroxine Test Kit & NDS Thyroxine CalibratorKLI · Traditional | 03/29/1990SE |
| K894947 | Platelia Toxo Igg KitLGO · Traditional | 03/23/1990SE |
| K894948 | Platelia Toxo Igm KitLGD · Traditional | 03/15/1990SE |
Questions and answers
When was NDS Cortisol Test Kit and NDS Cortisol Calibrator cleared by the FDA?
NDS Cortisol Test Kit and NDS Cortisol Calibrator (K900010) received a 510(k) decision of Substantially Equivalent on April 3, 1990, 91 days after the submission was received.
What is the product code of K900010?
The FDA product code is JFT – Fluorometric, Cortisol, a Class II (moderate risk) device regulated under 21 CFR 862.1205.