Synelisa Progesterone
FDA 510(k) K933128 · Elias U.S.A., Inc.
510(k) numberK933128
Submission
- Device name
- Synelisa Progesterone
- Applicant
- Elias U.S.A., Inc.
Osceola, WI, US - Received
- June 28, 1993
- Decision date
- November 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K964385 | Elias ANA-HEP-2LJM · Traditional | 03/06/1997SE |
| K963291 | Varelisa Ana (4) ProfileLJM · Traditional | 09/30/1996SE |
| K953873 | Varelisa Helicobacter Pylori AntibodiesLYR · Traditional | 08/30/1996SE |
| K953587 | Varelisa Mpo-AncaMOB · Traditional | 01/26/1996SE |
| K953586 | Varelisa PR3-ANCAMOB · Traditional | 01/26/1996SE |
| K951187 | Varelisa Cardiolipin Abs ScreenMID · Traditional | 10/02/1995SE |
| K951207 | Varelisa Histone AntibodiesLJM · Traditional | 04/17/1995SE |
| K951206 | Varelisa Parietal Cell AntibodiesMLE · Traditional | 04/17/1995SE |
| K951205 | Varelisa Ana ProfileLJM · Traditional | 04/17/1995SE |
| K951186 | Varelisa ANA-4 ScreenLJM · Traditional | 04/17/1995SE |
Questions and answers
When was Synelisa Progesterone cleared by the FDA?
Synelisa Progesterone (K933128) received a 510(k) decision of Substantially Equivalent on November 5, 1993, 130 days after the submission was received.
What is the product code of K933128?
The FDA product code is JLS – Radioimmunoassay, Progesterone, a Class I (low risk) device regulated under 21 CFR 862.1620.