Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

GRM — Predicate Candidate Screening

69 FDA 510(k) clearances under this product code; the 50 most recent screened below.

48 daysmedian FDA review time

74 days90th percentile

69clearances measured

K-number	Device	Applicant	Decided	Review days
K961960	SAS SALMONELLA H Z4, Z24 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961952	SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS	Sa Scientific, Inc.	1996-06-18	29
K961963	SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961967	SAS SALMONELLA O POLY B ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961957	SAS SALMONELLA H Z4, Z32 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961951	SAS SALMONELLA O FACTOR 6 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961956	SAS SALMONELLA H G,M,Q ANTISERMU	Sa Scientific, Inc.	1996-06-18	29
K961962	SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961948	SAS SALMONELLA O FACTOR 20 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961958	SAS SALMONELLA H Z4 COMPLEX ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961961	SAS SALMONELLA H F,G,T ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961954	SAS SALMONELLA H Z35 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961953	SAS SALMONELA H Z24 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961949	SAS SALMONELLA O FACTOR 14 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961966	SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961964	SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K961950	SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR	Sa Scientific, Inc.	1996-06-18	29
K961955	SAS SALMONELLA H Z42 ANTISERUM	Sa Scientific, Inc.	1996-06-18	29
K960160	SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM	Sa Scientific, Inc.	1996-03-12	61
K960129	SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM	Sa Scientific, Inc.	1996-03-12	61
K960461	SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM	Sa Scientific, Inc.	1996-03-12	42
K960130	SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM	Sa Scientific, Inc.	1996-03-12	61
K960147	SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM	Sa Scientific, Inc.	1996-03-12	61
K960136	SAS SALMONELLA H P ANTISERUM	Sa Scientific, Inc.	1996-03-06	50
K960163	SAS SALMONELLA 0 FACTOR FACTOR 5 ANTISERUM	Sa Scientific, Inc.	1996-03-06	55
K960124	SAS SALMONELLA 0 FACTOR 10 ANTISERUM AND/OR SAS SALMONELLA 0	Sa Scientific, Inc.	1996-03-06	55
K960465	SAS SALMONELLA O GROUP P FACTOR 38 ANTISERUM	Sa Scientific, Inc.	1996-03-06	36
K960463	SAS SALMONELLA O GROUP U FACTOR 43 ANTISERUM	Sa Scientific, Inc.	1996-03-06	36
K960135	SAS SALMONELLA H M ANTISERUM	Sa Scientific, Inc.	1996-03-06	50
K960162	SAS SALMONELLA 0 GROUP 0 FACTOR 35 ANTISERUM	Sa Scientific, Inc.	1996-03-06	55
K960127	SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O G	Sa Scientific, Inc.	1996-03-06	55
K960134	SAS SALMONELLA 0 FACTOR 9 ANTISERUM AND/OR SAS SALMONELLA 0	Sa Scientific, Inc.	1996-03-06	55
K960138	SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND/OR SAS SALMONELLA 0	Sa Scientific, Inc.	1996-03-06	55
K960145	SAS SALMONELLA 0 FACTOR 27 ANTISERUM	Sa Scientific, Inc.	1996-03-06	55
K960137	SAS SALMONELLA H Z10 ANTISERUM	Sa Scientific, Inc.	1996-03-06	50
K960152	SAS SALMONELLA 0 FACTOR 12 ANTISERUM	Sa Scientific, Inc.	1996-03-06	55
K960140	SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GR	Sa Scientific, Inc.	1996-03-06	55
K960460	SAS SALMONELLA O FACTOR 46 ANTISERUM	Sa Scientific, Inc.	1996-03-06	36
K960123	SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O G	Sa Scientific, Inc.	1996-03-06	55
K960150	SAS SALMONELLA 0 GROUP J FACTOR 17 ANTISERUM	Sa Scientific, Inc.	1996-03-06	55
K960459	SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM	Sa Scientific, Inc.	1996-03-06	36
K960462	SAS SALMONELLA O GROUP Q FACTOR 39 ANTISERUM	Sa Scientific, Inc.	1996-03-06	36
K960126	SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O G	Sa Scientific, Inc.	1996-03-06	55
K960153	SAS SALOMNELLA 0 GROUP L FACTOR 21 ANTISERUM	Sa Scientific, Inc.	1996-03-06	55
K960142	SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0	Sa Scientific, Inc.	1996-03-06	55
K960149	SAS SALMONELLA 0 GROUP F FACTOR 11 ANTISERUM	Sa Scientific, Inc.	1996-03-06	55
K960458	SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM	Sa Scientific, Inc.	1996-03-06	36
K960125	SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GR	Sa Scientific, Inc.	1996-03-06	55
K960161	SAS SALMONELLA 0 GROUP N FACTOR 30 ANTISERUM	Sa Scientific, Inc.	1996-03-06	55
K960132	SAS SALMONELLA H U ANTISERUM	Sa Scientific, Inc.	1996-03-06	50

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