Leeco Progesterone-Quant Diagnostic Test Kit
FDA 510(k) K850056 · Leeco Diagnostics, Inc.
510(k) numberK850056
Submission
- Device name
- Leeco Progesterone-Quant Diagnostic Test Kit
- Applicant
- Leeco Diagnostics, Inc.
Southfield, MI, US - Received
- January 8, 1985
- Decision date
- February 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JLS – Radioimmunoassay, Progesterone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1620
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JLS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040923 | Luminescent Immunoassay Kit for the Detection of Progesterone in SalivaJLS · Traditional | Ibl GmbH | 07/22/2004SE |
| K973898 | Progesterone ElisaJLS · Traditional | Kmi Diagnostics, Inc. | 11/13/1997SE |
| K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone…JLS · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 06/24/1997SE |
| K971725 | Opus ProgesteroneJLS · Traditional | Behring Diagnostics, Inc. | 06/18/1997SE |
| K964841 | Elecsys Progesterone AssayJLS · Traditional | Boehringer Mannheim Corp. | 03/24/1997SE |
| K965084 | Vidas Proesterone (PRG) (30 409)JLS · Traditional | bioMerieux, Inc. | 01/09/1997SE |
| K955025 | Axsym ProgesteroneJLS · Traditional | Abbott Laboratories | 03/07/1996SE |
| K955769 | Access Progesterone AssayJLS · Traditional | Bio-Rad Laboratories, Inc. | 02/05/1996SE |
| K952075 | Progesterone Assay for the Technicon Immuno 1 System In-Bitro Diagnostic SystemJLS · Traditional | Bayer Corp. | 06/13/1995SE |
| K951630 | Auraflex Progesterone 150TEST PackJLS · Traditional | Organon Teknika Corp. | 05/08/1995SE |
More from Organon Teknika Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K895765 | Leeco Preview(R) Ebv (Eia)KTN · Traditional | 10/31/1989SE |
| K894122 | Leeco Vis-Disk Strep-A (Eia)GTZ · Traditional | 08/15/1989SE |
| K891096 | Vis-Disk HCG (Eia) JPL-041MDHA · Traditional | 06/16/1989SE |
| K891095 | Vis-Disk HCG (Eia) Lyophilized JPL-044MDHA · Traditional | 06/16/1989SE |
| K883269 | Prl-QuantCFT · Traditional | 09/13/1988SE |
| K880577 | CONCEP-7-BHCGJHI · Traditional | 03/15/1988SE |
| K880069 | Leeco Pregnastick (Eia) Catalog #003LCX · Traditional | 02/11/1988SE |
| K870259 | Vis-Cube HCG (Eia) Lyophilized JPL-044JHI · Traditional | 03/10/1987SE |
| K864170 | Leeco Vis-Cube Strep a (Eia)GTZ · Traditional | 02/03/1987SE |
| K863999 | Vis-Cube Pregnancy Home Test,Cat. # JPL-042LCX · Traditional | 01/09/1987SE |
Questions and answers
When was Leeco Progesterone-Quant Diagnostic Test Kit cleared by the FDA?
Leeco Progesterone-Quant Diagnostic Test Kit (K850056) received a 510(k) decision of Substantially Equivalent on February 6, 1985, 29 days after the submission was received.
What is the product code of K850056?
The FDA product code is JLS – Radioimmunoassay, Progesterone, a Class I (low risk) device regulated under 21 CFR 862.1620.