SA Scientific, Ltd
San Antonio, TX, US
SA SCIENTIFIC, LTD appears in FDA device records in San Antonio, TX. FDA records list 201 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 201FDA records hold 201 510(k) clearances for SA Scientific, Ltd between 1993 and 2013. The busiest year on record is 1996, with 126. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 5 |
| 1994 | 4 |
| 1995 | 41 |
| 1996 | 126 |
| 1997 | 3 |
| 1999 | 7 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 3 |
| 2003 | 2 |
| 2004 | 2 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K132352 | SAS FLUALERT A & B, SAS INFLUENZA A TEST | GNX | Substantially Equivalent | |
| K100227 | SAS FLUALERT A&B, SAS INFLUENZA A TEST | PSZ | Substantially Equivalent | |
| K080380 | SAS INFLUENZA A & B TEST | PSZ | Substantially Equivalent | |
| K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | MJH | Substantially Equivalent | |
| K041441 | SAS INFLUENZA A TEST | PSZ | Substantially Equivalent | |
| K041439 | SAS INFLUENZA B TEST | PSZ | Substantially Equivalent | |
| K030628 | SAS RSV CONTROL KIT | JJX | Substantially Equivalent | |
| K022845 | SAS RSV TEST | GQG | Substantially Equivalent | |
| K022683 | SAS BLOOD/SERUM/URINE/URINE HCG | JHI | Substantially Equivalent | |
| K023270 | SAS STREPALERT | GTY | Substantially Equivalent | |
| K020438 | SAS VALUE HCG | JHI | Substantially Equivalent | |
| K013379 | SAS STREPALERT | GTY | Substantially Equivalent | |
| K010522 | SUREVUE URINE HCG | JHI | Substantially Equivalent | |
| K010593 | SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT | JHI | Substantially Equivalent | |
| K993456 | SAS STREP A TEST | GTY | Substantially Equivalent | |
| K990630 | SAS ADENO TEST | GOD | Substantially Equivalent | |
| K990842 | SAS ROTA TEST | LIQ | Substantially Equivalent | |
| K990741 | SAS ONE-STEP PREGNANCY | JHI | Substantially Equivalent | |
| K990684 | MODIFICATION OF SAS SERUM/URINE HCG | JHI | Substantially Equivalent | |
| K991193 | SAS HCG-CHECK | LCX | Substantially Equivalent | |
| K990755 | SAS HCG URINE CONTROLS | JJX | Substantially Equivalent | |
| K990720 | SAS HCG SERUM CONTROLS | JJX | Substantially Equivalent | |
| K974154 | CHOICE ACCU-TEST PREGNANCY TEST KIT | LCX | Substantially Equivalent | |
| K974021 | SIGNAL PREGNANCY TEST KIT | LCX | Substantially Equivalent | |
| K964995 | SAS ONE-STEP PREGNANCY | JHI | Substantially Equivalent | |
| K960947 | SAS SICKLE CELL TEST | GHM | Substantially Equivalent | |
| K961967 | SAS SALMONELLA O POLY B ANTISERUM | GRM | Substantially Equivalent | |
| K961966 | SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM | GRM | Substantially Equivalent | |
| K961964 | SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM | GRM | Substantially Equivalent | |
| K961963 | SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM | GRM | Substantially Equivalent | |
| K961962 | SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM | GRM | Substantially Equivalent | |
| K961961 | SAS SALMONELLA H F,G,T ANTISERUM | GRM | Substantially Equivalent | |
| K961960 | SAS SALMONELLA H Z4, Z24 ANTISERUM | GRM | Substantially Equivalent | |
| K961958 | SAS SALMONELLA H Z4 COMPLEX ANTISERUM | GRM | Substantially Equivalent | |
| K961957 | SAS SALMONELLA H Z4, Z32 ANTISERUM | GRM | Substantially Equivalent | |
| K961956 | SAS SALMONELLA H G,M,Q ANTISERMU | GRM | Substantially Equivalent | |
| K961955 | SAS SALMONELLA H Z42 ANTISERUM | GRM | Substantially Equivalent | |
| K961954 | SAS SALMONELLA H Z35 ANTISERUM | GRM | Substantially Equivalent | |
| K961953 | SAS SALMONELA H Z24 ANTISERUM | GRM | Substantially Equivalent | |
| K961952 | SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS | GRM | Substantially Equivalent | |
| K961951 | SAS SALMONELLA O FACTOR 6 ANTISERUM | GRM | Substantially Equivalent | |
| K961950 | SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM | GRM | Substantially Equivalent | |
| K961949 | SAS SALMONELLA O FACTOR 14 ANTISERUM | GRM | Substantially Equivalent | |
| K961948 | SAS SALMONELLA O FACTOR 20 ANTISERUM | GRM | Substantially Equivalent | |
| K961537 | SAS SHIGELLA SONNEI FORM II ANTISERUM | GNB | Substantially Equivalent | |
| K961559 | SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM | GNB | Substantially Equivalent | |
| K961558 | SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM | GNB | Substantially Equivalent | |
| K961556 | SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM | GNB | Substantially Equivalent | |
| K961554 | SAS SHIGELLA BOYDII TYPE 10 ANTISERUM | GNB | Substantially Equivalent | |
| K961553 | SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM | GNB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1645225 | 1000118544 | SA SCIENTIFIC, LTD | 4919 GOLDEN QUAIL, SAN ANTONIO, TX 78240 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GSOAntigens (Febrile), Agglutination, Brucella Spp.
- GRLAntigens, All Groups, Salmonella Spp.
- GTYAntigens, All Groups, Streptococcus Spp.
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-33
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
- GQBAntigens, Cf (Including Cf Control), Reovirus 1-3
- GNCAntigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
- GSLAntigens, Slide And Tube, Francisella Tularensis
- GRMAntisera, All Groups, Salmonella Spp.
- GNBAntisera, All Types, Shigella Spp.
- GSMAntisera, Fluorescent, Brucella Spp.
- GSKAntiserum, Francisella Tularensis
- GSNAntiserum, Positive And Negative Febrile Antigen Control Serum
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- LRFCandida Spp., Direct Antigen, Id
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- MJHLegionella, Spp., Elisa
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHASystem, Test, Human Chorionic Gonadotropin
- GHMTest, Sickle Cell
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain