Liquisol Progesterone Radioimmuno
FDA 510(k) K820686 · Damon Corp.
510(k) numberK820686
Submission
- Device name
- Liquisol Progesterone Radioimmuno
- Applicant
- Damon Corp.
Mchenry, IL, US - Received
- March 11, 1982
- Decision date
- April 1, 1982
- 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 |
|---|---|---|
| K874865 | Damon D.E.T.E.C.T Image EnhancerLLZ · Traditional | 12/23/1987SE |
| K831826 | Adrenocorticotropin Radio-ImmunoassayCKG · Traditional | 07/18/1983SE |
| K802661 | Liquisol Testosterone Radioimm. Test KitCDZ · Traditional | 12/10/1980SE |
| K790250 | Liquisol Cortisol Ria Test Kit · Traditional | 04/04/1979SE |
| K782124 | Iec CENTRA-7 Centrifuge Model 2362JQC · Traditional | 02/26/1979SE |
| K781012 | Ria Test Kit Sys. Damon Kiquisol FreeCEC · Traditional | 07/27/1978SE |
| K780207 | Liquisol Digoxin Ria Test KitDON · Traditional | 02/23/1978SE |
| K770918 | Liqui Sol T4 Ria Test KitCDP · Traditional | 06/17/1977SE |
| K770606 | Analyzeo, Plasma, Blood, ColysagraphJPA · Traditional | 05/06/1977SE |
| K761013 | Spinette CentrifugeJQC · Traditional | 11/16/1976SE |
Questions and answers
When was Liquisol Progesterone Radioimmuno cleared by the FDA?
Liquisol Progesterone Radioimmuno (K820686) received a 510(k) decision of Substantially Equivalent on April 1, 1982, 21 days after the submission was received.
What is the product code of K820686?
The FDA product code is JLS – Radioimmunoassay, Progesterone, a Class I (low risk) device regulated under 21 CFR 862.1620.