RSL (125 L) Progesterone Kit
FDA 510(k) K800126 · Radioassay Systems Laboratories, Inc.
510(k) numberK800126
Submission
- Device name
- RSL (125 L) Progesterone Kit
- Applicant
- Radioassay Systems Laboratories, Inc.
Mchenry, IL, US - Received
- January 18, 1980
- Decision date
- February 13, 1980
- 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 |
|---|---|---|
| K862204 | RSL (125I) Aldosterone KitCJM · Traditional | 09/25/1986SE |
| K842960 | Androstenedione by RiaCIZ · Traditional | 09/27/1984SE |
| K840886 | Hydroxyprogesterone by Ria 17AJLS · Traditional | 04/18/1984SE |
| K831855 | Hatch KitCKG · Traditional | 07/28/1983SE |
| K802195 | Dehydroepiandrosterone Sulfate Kit RiaJKC · Traditional | 10/23/1980SE |
| K791999 | (125I) Testosterone KitCDZ · Traditional | 10/30/1979SE |
| K791835 | Coralent Coat 125I Cortisol Radioimm.CGR · Traditional | 09/27/1979SE |
| K791740 | Serum 11-DESOXYCORTISOL I AS TracerJKB · Traditional | 09/27/1979SE |
| K791728 | Rsl's Assay Procedure QuantitationCGI · Traditional | 09/27/1979SE |
| K791652 | Estradiol Kit by RiaCHP · Traditional | 09/27/1979SE |
Questions and answers
When was RSL (125 L) Progesterone Kit cleared by the FDA?
RSL (125 L) Progesterone Kit (K800126) received a 510(k) decision of Substantially Equivalent on February 13, 1980, 26 days after the submission was received.
What is the product code of K800126?
The FDA product code is JLS – Radioimmunoassay, Progesterone, a Class I (low risk) device regulated under 21 CFR 862.1620.