Data / Medical devices / United States / SA Scientific, Ltd
SA Scientific, Ltd: FDA-registered device maker in San Antonio, TX, United States, 11 510(k) clearances
SA Scientific, Ltd is registered with the FDA (registration 1645225) in San Antonio, TX, United States. It lists 12 device types. The FDA files 11 510(k) clearances under its listings, the newest dated July 23, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1645225
- FEI number
- 1000118544
- Address
- 4919 Golden Quail, San Antonio, TX, United States, 78240
- Owner or operator
- SA Scientific, Ltd (9004843)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 25, 1999
- Registered through
- 2026
- Brand names listed
- SAS, SAS ADENO TEST, SAS ASO-LATEX, SAS CANDIDA ANTISERA, SAS FluAlert A&B Test, SAS Influenza A Test, SAS Influenza B Test, SAS Legionella Test and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| July 23, 2009 | K080380 | SAS INFLUENZA A & B TEST | PSZ | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| June 28, 2007 | K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | MJH | Substantially Equivalent | Sa Scientific , Ltd. | accessdata.fda.gov |
| July 22, 2004 | K041441 | SAS INFLUENZA A TEST | PSZ | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| July 22, 2004 | K041439 | SAS INFLUENZA B TEST | PSZ | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| October 17, 2002 | K023270 | SAS STREPALERT | GTY | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| May 10, 1999 | K990684 | MODIFICATION OF SAS SERUM/URINE HCG | JHI | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| May 4, 1999 | K991193 | SAS HCG-CHECK | LCX | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| February 18, 1997 | K965250 | SAS SERUM/URINE HCG | JHI | Substantially Equivalent | Sascie | accessdata.fda.gov |
| July 1, 1996 | K960947 | SAS SICKLE CELL TEST | GHM | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| January 17, 1995 | K944785 | SAS QUANT HCG SERUM | JJX | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| November 17, 1994 | K944891 | SAS QUANT HCG URINE | JJX | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Sickle Cell
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Devices Detecting Influenza A, B, And C Virus Antigens
- All makers of Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- All makers of Legionella, Spp., Elisa
- All makers of Antigens, Cf (Including Cf Control), Adenovirus 1-33
Updated July 23, 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.