Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sa Scientific, Inc. — Predicate Candidate Screening
199 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
91 days90th percentile
199clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100227 | SAS FLUALERT A&B, SAS INFLUENZA A TEST | Sa Scientific, Inc. | 2010-02-23 | 28 | 0 |
| K080380 | SAS INFLUENZA A & B TEST | Sa Scientific, Inc. | 2009-07-23 | 526 | 0 |
| K041441 | SAS INFLUENZA A TEST | Sa Scientific, Inc. | 2004-07-22 | 51 | 0 |
| K041439 | SAS INFLUENZA B TEST | Sa Scientific, Inc. | 2004-07-22 | 51 | 0 |
| K030628 | SAS RSV CONTROL KIT | Sa Scientific, Inc. | 2003-03-17 | 18 | 0 |
| K022845 | SAS RSV TEST | Sa Scientific, Inc. | 2003-01-29 | 155 | 0 |
| K022683 | SAS BLOOD/SERUM/URINE/URINE HCG | Sa Scientific, Inc. | 2002-12-16 | 126 | 0 |
| K023270 | SAS STREPALERT | Sa Scientific, Inc. | 2002-10-17 | 16 | 0 |
| K020438 | SAS VALUE HCG | Sa Scientific, Inc. | 2002-03-08 | 25 | 0 |
| K013379 | SAS STREPALERT | Sa Scientific, Inc. | 2001-12-12 | 61 | 0 |
| K010522 | SUREVUE URINE HCG | Sa Scientific, Inc. | 2001-07-31 | 159 | 0 |
| K010593 | SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT | Sa Scientific, Inc. | 2001-04-05 | 36 | 0 |
| K993456 | SAS STREP A TEST | Sa Scientific, Inc. | 2000-03-07 | 146 | 0 |
| K990630 | SAS ADENO TEST | Sa Scientific, Inc. | 1999-08-19 | 174 | 0 |
| K990842 | SAS ROTA TEST | Sa Scientific, Inc. | 1999-08-09 | 147 | 0 |
| K990741 | SAS ONE-STEP PREGNANCY | Sa Scientific, Inc. | 1999-05-10 | 63 | 0 |
| K990684 | MODIFICATION OF SAS SERUM/URINE HCG | Sa Scientific, Inc. | 1999-05-10 | 68 | 0 |
| K991193 | SAS HCG-CHECK | Sa Scientific, Inc. | 1999-05-04 | 26 | 0 |
| K990720 | SAS HCG SERUM CONTROLS | Sa Scientific, Inc. | 1999-03-19 | 14 | 0 |
| K990755 | SAS HCG URINE CONTROLS | Sa Scientific, Inc. | 1999-03-19 | 11 | 0 |
| K974154 | CHOICE ACCU-TEST PREGNANCY TEST KIT | Sa Scientific, Inc. | 1997-12-19 | 45 | 0 |
| K974021 | SIGNAL PREGNANCY TEST KIT | Sa Scientific, Inc. | 1997-12-19 | 58 | 0 |
| K964995 | SAS ONE-STEP PREGNANCY | Sa Scientific, Inc. | 1997-01-21 | 36 | 0 |
| K960947 | SAS SICKLE CELL TEST | Sa Scientific, Inc. | 1996-07-01 | 115 | 0 |
| K961960 | SAS SALMONELLA H Z4, Z24 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961952 | SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961963 | SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961967 | SAS SALMONELLA O POLY B ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961957 | SAS SALMONELLA H Z4, Z32 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961951 | SAS SALMONELLA O FACTOR 6 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961956 | SAS SALMONELLA H G,M,Q ANTISERMU | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961962 | SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961948 | SAS SALMONELLA O FACTOR 20 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961958 | SAS SALMONELLA H Z4 COMPLEX ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961961 | SAS SALMONELLA H F,G,T ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961954 | SAS SALMONELLA H Z35 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961953 | SAS SALMONELA H Z24 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961949 | SAS SALMONELLA O FACTOR 14 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961966 | SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961964 | SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961950 | SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961955 | SAS SALMONELLA H Z42 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 | 29 | 0 |
| K961537 | SAS SHIGELLA SONNEI FORM II ANTISERUM | Sa Scientific, Inc. | 1996-05-31 | 39 | 0 |
| K961528 | SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961551 | SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961532 | SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961546 | SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961529 | SAS SHIGELLA BOYDII TYPE 12 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961535 | SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
| K961534 | SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) | Sa Scientific, Inc. | 1996-05-20 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda