Company ยท US
Sa Scientific, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2013. Name variants (Inc, Corp, punctuation) are merged.
201510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GRM | Antisera, All Groups, Salmonella Spp. | 64 |
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. | 49 |
| GNB | Antisera, All Types, Shigella Spp. | 38 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 9 |
| GSO | Antigens (Febrile), Agglutination, Brucella Spp. | 7 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 |
| GSM | Antisera, Fluorescent, Brucella Spp. | 4 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 4 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 4 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 3 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| GHM | Test, Sickle Cell | 1 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 1 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 |
| GRL | Antigens, All Groups, Salmonella Spp. | 1 |
| GSK | Antiserum, Francisella Tularensis | 1 |
| GSL | Antigens, Slide And Tube, Francisella Tularensis | 1 |
| GSN | Antiserum, Positive And Negative Febrile Antigen Control Serum | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 22, 2013 | K132352 | SAS FLUALERT A & B, SAS INFLUENZA A TEST Sa Scientific , Ltd. | GNX |
| Feb 23, 2010 | K100227 | SAS FLUALERT A&B, SAS INFLUENZA A TEST Sa Scientific, Inc. | PSZ |
| Jul 23, 2009 | K080380 | SAS INFLUENZA A & B TEST Sa Scientific, Inc. | PSZ |
| Jun 28, 2007 | K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST Sa Scientific , Ltd. | MJH |
| Jul 22, 2004 | K041441 | SAS INFLUENZA A TEST Sa Scientific, Inc. | PSZ |
| Jul 22, 2004 | K041439 | SAS INFLUENZA B TEST Sa Scientific, Inc. | PSZ |
| Mar 17, 2003 | K030628 | SAS RSV CONTROL KIT Sa Scientific, Inc. | JJX |
| Jan 29, 2003 | K022845 | SAS RSV TEST Sa Scientific, Inc. | GQG |
| Dec 16, 2002 | K022683 | SAS BLOOD/SERUM/URINE/URINE HCG Sa Scientific, Inc. | JHI |
| Oct 17, 2002 | K023270 | SAS STREPALERT Sa Scientific, Inc. | GTY |
| Mar 8, 2002 | K020438 | SAS VALUE HCG Sa Scientific, Inc. | JHI |
| Dec 12, 2001 | K013379 | SAS STREPALERT Sa Scientific, Inc. | GTY |
| Jul 31, 2001 | K010522 | SUREVUE URINE HCG Sa Scientific, Inc. | JHI |
| Apr 5, 2001 | K010593 | SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT Sa Scientific, Inc. | JHI |
| Mar 7, 2000 | K993456 | SAS STREP A TEST Sa Scientific, Inc. | GTY |
| Aug 19, 1999 | K990630 | SAS ADENO TEST Sa Scientific, Inc. | GOD |
| Aug 9, 1999 | K990842 | SAS ROTA TEST Sa Scientific, Inc. | LIQ |
| May 10, 1999 | K990741 | SAS ONE-STEP PREGNANCY Sa Scientific, Inc. | JHI |
| May 10, 1999 | K990684 | MODIFICATION OF SAS SERUM/URINE HCG Sa Scientific, Inc. | JHI |
| May 4, 1999 | K991193 | SAS HCG-CHECK Sa Scientific, Inc. | LCX |
| Mar 19, 1999 | K990755 | SAS HCG URINE CONTROLS Sa Scientific, Inc. | JJX |
| Mar 19, 1999 | K990720 | SAS HCG SERUM CONTROLS Sa Scientific, Inc. | JJX |
| Dec 19, 1997 | K974154 | CHOICE ACCU-TEST PREGNANCY TEST KIT Sa Scientific, Inc. | LCX |
| Dec 19, 1997 | K974021 | SIGNAL PREGNANCY TEST KIT Sa Scientific, Inc. | LCX |
| Jan 21, 1997 | K964995 | SAS ONE-STEP PREGNANCY Sa Scientific, Inc. | JHI |
| Jul 1, 1996 | K960947 | SAS SICKLE CELL TEST Sa Scientific, Inc. | GHM |
| Jun 18, 1996 | K961967 | SAS SALMONELLA O POLY B ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961966 | SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961964 | SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961963 | SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961962 | SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961961 | SAS SALMONELLA H F,G,T ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961960 | SAS SALMONELLA H Z4, Z24 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961958 | SAS SALMONELLA H Z4 COMPLEX ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961957 | SAS SALMONELLA H Z4, Z32 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961956 | SAS SALMONELLA H G,M,Q ANTISERMU Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961955 | SAS SALMONELLA H Z42 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961954 | SAS SALMONELLA H Z35 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961953 | SAS SALMONELA H Z24 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961952 | SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961951 | SAS SALMONELLA O FACTOR 6 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961950 | SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961949 | SAS SALMONELLA O FACTOR 14 ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 18, 1996 | K961948 | SAS SALMONELLA O FACTOR 20 ANTISERUM Sa Scientific, Inc. | GRM |
| May 31, 1996 | K961537 | SAS SHIGELLA SONNEI FORM II ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961559 | SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961558 | SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961556 | SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961554 | SAS SHIGELLA BOYDII TYPE 10 ANTISERUM Sa Scientific, Inc. | GNB |
| May 20, 1996 | K961553 | SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM Sa Scientific, Inc. | GNB |
Newest 50 of 201.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||