Ria-Gnost Progesterone
FDA 510(k) K890836 · Cambridge Medical Technology
510(k) numberK890836
Submission
- Device name
- Ria-Gnost Progesterone
- Applicant
- Cambridge Medical Technology
Billerica, MA, US - Received
- February 21, 1989
- Decision date
- March 16, 1989
- 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 |
|---|---|---|
| K890837 | Ria-Gnost InsulinCFP · Traditional | 04/26/1989SE |
| K890697 | Ria-Gnost FerritinJMG · Traditional | 03/16/1989SE |
| K873737 | No Spin(Tm) T3 Coated Tube RadioimmunoassayCDP · Traditional | 11/24/1987SE |
| K870573 | T4 No Spin(Tm) Coated Tube Radioimmunoassay KitCDX · Traditional | 04/22/1987SE |
| K862871 | Radioimmunoassay of No Spin(Tm) CortisolCGR · Traditional | 08/19/1986SE |
| K860130 | Testosterone Coated Tubes Radioimmunoassay KitCDZ · Traditional | 02/19/1986SE |
| K855169 | T3 Uptake Radioimmunoassay KitKHQ · Traditional | 02/06/1986SE |
| K850254 | Parathyroid Hormone Radioimmunoassay KitCEW · Traditional | 04/03/1985SE |
| K843635 | Matched Component Set for Radioimmuno-JKC · Traditional | 09/28/1984SE |
| K841042 | Matched Component Set RadioimmunoassayCDZ · Traditional | 04/19/1984SE |
Questions and answers
When was Ria-Gnost Progesterone cleared by the FDA?
Ria-Gnost Progesterone (K890836) received a 510(k) decision of Substantially Equivalent on March 16, 1989, 23 days after the submission was received.
What is the product code of K890836?
The FDA product code is JLS – Radioimmunoassay, Progesterone, a Class I (low risk) device regulated under 21 CFR 862.1620.