Progesterone Radioimmunoassay Kit
FDA 510(k) K791051 · Cis Radiopharmaceuticals, Inc.
510(k) numberK791051
Submission
- Device name
- Progesterone Radioimmunoassay Kit
- Applicant
- Cis Radiopharmaceuticals, Inc.
Mchenry, IL, US - Received
- June 6, 1979
- Decision date
- July 24, 1979
- 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 |
|---|---|---|
| K791860 | Ferritin Ria KitDBF · Traditional | 12/06/1979SE |
| K792063 | Follicle Stimulating Hormone (FSH) KitCGJ · Traditional | 11/20/1979SE |
| K791202 | Ria Kit for TrypsinJNO · Traditional | 11/05/1979SE |
| K792000 | Luteinizing Hormone (LH) RiaCEP · Traditional | 10/30/1979SE |
| K790003 | Ria Kit, ProlactinCFT · Traditional | 03/12/1979SE |
| K780982 | Kits, Ria, Myoglobin, Human, MeasurementDDR · Traditional | 06/22/1978SE |
| K771878 | Iridium 192 Wires & PinsIWA · Traditional | 10/27/1977SE |
| K760251 | Set, Oral AdministrationLEY · Traditional | 09/15/1976SE |
Questions and answers
When was Progesterone Radioimmunoassay Kit cleared by the FDA?
Progesterone Radioimmunoassay Kit (K791051) received a 510(k) decision of Substantially Equivalent on July 24, 1979, 48 days after the submission was received.
What is the product code of K791051?
The FDA product code is JLS – Radioimmunoassay, Progesterone, a Class I (low risk) device regulated under 21 CFR 862.1620.