Data / Medical devices / Israel / Savyon Diagnostics Ltd.
Savyon Diagnostics Ltd.: FDA-registered device maker in ASHDOD Southern, Israel, 10 510(k) clearances
Savyon Diagnostics Ltd. is registered with the FDA (registration 8030124) in ASHDOD Southern, Israel. It lists 13 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 31, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8030124
- FEI number
- 3003206361
- Address
- 3 Habosem ST., ASHDOD Southern, Israel, 7761003
- Owner or operator
- SAVYON DIAGNOSTICS, LTD. (8030129)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 13, 2000
- Registered through
- 2026
- Brand names listed
- AL-SENSE; AmniScreen(TM), Analyte specific reagent, Bordetella Pertussis IgG, Bordetella immunology reagents IgA, Bordetella immunology reagents IgM, CHROMOSTREAK, Clinistix Vaginal Health Test Kit; Equate; Feminine Screening Kit, DIASLIDE URINE CULTURING DEVICE, DIPSTREAK and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antisera, Fluorescent, B. Pertussis | GOZ | 1 | Manufacturer | accessdata.fda.gov |
| Candida Spp., Direct Antigen, Id | LRF | 2 | Manufacturer | accessdata.fda.gov |
| Culture Media, Propagating Transport | JSN | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Selective And Differential | JSI | 1 | Manufacturer | accessdata.fda.gov |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | 1 | Manufacturer | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | LJC | 1 | Manufacturer | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Kit, Screening, Urine | JXA | 1 | Manufacturer | accessdata.fda.gov |
| Reagent, Immunoassay, Igg | KTO | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Contract manufacturer | accessdata.fda.gov |
| Uroflowmeter | EXY | 2 | Manufacturer | accessdata.fda.gov |
| Whole Human Serum, Antigen, Antiserum, Control | DGR | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 31, 2009 | K091287 | VS-SENSE TEST | CEN | Substantially Equivalent | Common Sense , Ltd. | accessdata.fda.gov |
| October 15, 2007 | K071100 | AMNISCREEN HOME DETECTION LINER KIT | CEN | Substantially Equivalent | Common Sense , Ltd. | accessdata.fda.gov |
| August 24, 2000 | K000718 | CHROMOSTREAK | JSN | Substantially Equivalent | Novamed , Ltd. | accessdata.fda.gov |
| October 7, 1998 | K981084 | URISCREEN | JXA | Substantially Equivalent | Diatech Diagnostics,Inc. | accessdata.fda.gov |
| July 30, 1998 | K974428 | DIPSTREAK | JSI | Substantially Equivalent | Novamed , Ltd. | accessdata.fda.gov |
| September 28, 1992 | K921045 | DIASLIDE URINE CULTURING DEVICE | JXA | Substantially Equivalent | Savyon Diagnostics , Ltd. | accessdata.fda.gov |
| June 9, 1992 | K914327 | SEROELISA(TM) CHLAMYDIA IGA TEST KIT | LJC | Substantially Equivalent | Savyon Diagnostics , Ltd. | accessdata.fda.gov |
| March 23, 1992 | K915281 | SEROLISA CHLAMYDIA IGG TEST KIT | LJC | Substantially Equivalent | Savyon Diagnostics , Ltd. | accessdata.fda.gov |
| June 21, 1989 | K882596 | MP TEST | LJZ | Substantially Equivalent | Diatech Diagnostica , Ltd. | accessdata.fda.gov |
| September 30, 1988 | K882211 | URISCREEN | JXA | Substantially Equivalent | Diatech Diagnostica , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Uroflowmeter
- All makers of Whole Human Serum, Antigen, Antiserum, Control
- All makers of Reagent, Immunoassay, Igg
- All makers of Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- All makers of Reagents, Specific, Analyte
Updated August 31, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.