Atlas FDA

GRM

69 FDA 510(k) clearances · Product code

48 daysmedian time to decision
74 days90th percentile
69clearances measured

FDA profile

Official device name
Antisera, All Groups, Salmonella Spp.
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3550
Medical specialty
Microbiology
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RecordFirmDate
SAS SALMONELLA H Z4, Z24 ANTISERUM (K961960)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS (K961952)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM (K961963)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O POLY B ANTISERUM (K961967)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA H Z4, Z32 ANTISERUM (K961957)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O FACTOR 6 ANTISERUM (K961951)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA H G,M,Q ANTISERMU (K961956)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM (K961962)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O FACTOR 20 ANTISERUM (K961948)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA H Z4 COMPLEX ANTISERUM (K961958)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA H F,G,T ANTISERUM (K961961)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA H Z35 ANTISERUM (K961954)Sa Scientific, Inc.1996-06-18
SAS SALMONELA H Z24 ANTISERUM (K961953)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O FACTOR 14 ANTISERUM (K961949)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM (K961966)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM (K961964)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM (K961950)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA H Z42 ANTISERUM (K961955)Sa Scientific, Inc.1996-06-18
SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM (K960160)Sa Scientific, Inc.1996-03-12
SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM (K960129)Sa Scientific, Inc.1996-03-12
SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM (K960461)Sa Scientific, Inc.1996-03-12
SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM (K960130)Sa Scientific, Inc.1996-03-12
SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM (K960147)Sa Scientific, Inc.1996-03-12
SAS SALMONELLA H P ANTISERUM (K960136)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR FACTOR 5 ANTISERUM (K960163)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 10 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP E1 FACTOR 10 ANTISERUM (K960124)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O GROUP P FACTOR 38 ANTISERUM (K960465)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O GROUP U FACTOR 43 ANTISERUM (K960463)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA H M ANTISERUM (K960135)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 GROUP 0 FACTOR 35 ANTISERUM (K960162)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O GROUP G1 FACTOR 22 ANTISERUM (K960127)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 9 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP D FACTOR 9 ANTISERUM (K960134)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C2 FACTOR 9 ANTISERUM (K960138)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 27 ANTISERUM (K960145)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA H Z10 ANTISERUM (K960137)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 12 ANTISERUM (K960152)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C1 FACTOR 7 ANTISERUM (K960140)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O FACTOR 46 ANTISERUM (K960460)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM (K960123)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 GROUP J FACTOR 17 ANTISERUM (K960150)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM (K960459)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O GROUP Q FACTOR 39 ANTISERUM (K960462)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O GROUP E4 FACTOR 19 ANTISERUM (K960126)Sa Scientific, Inc.1996-03-06
SAS SALOMNELLA 0 GROUP L FACTOR 21 ANTISERUM (K960153)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0 GROUP G2 FACTOR 23 ANTISERUM (K960142)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 GROUP F FACTOR 11 ANTISERUM (K960149)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM (K960458)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM (K960125)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA 0 GROUP N FACTOR 30 ANTISERUM (K960161)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA H U ANTISERUM (K960132)Sa Scientific, Inc.1996-03-06
SAS SALMONELLA H G,P,U ANTISERUM (K960333)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H F ANTISERUM (K960133)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H Z15 ANTISERUM (K960610)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H Z28 ANTISERUM (K960331)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H G ANTISERUM (K960131)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H Z23 ANTISERUM (K960603)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H POLY A-Z ANTISERUM (K960335)Sa Scientific, Inc.1996-03-04
SAS SALMONELLA H Z32 ANTISERUM (K960609)Sa Scientific, Inc.1996-03-04
SAS SPICER-EDWARDS 1 COMPLEX (K955222)Sa Scientific, Inc.1996-02-13
SAS SALMONELLA H C ANTISERUM (K952288)Sa Scientific, Inc.1995-07-25
SAS SALMONELLA H POLY POSITIVE ANTISERUM (K952134)Sa Scientific, Inc.1995-07-21
SAS SALMONELLA O POLY POSITIVE ANTISERUM (K952133)Sa Scientific, Inc.1995-07-21
SAS SALMONELLA H B ANTISERUM (K951069)Sa Scientific, Inc.1995-06-09
SAS SALMONELLA H D ANTISERUM (K943400)Sa Scientific, Inc.1994-11-02
SALMONELLA O GROUPING ANTISERA SET (K912791)S.M.I. Medical, Inc.1992-10-05
DIPSTICK SALMONELLA (K910438)Ampcor, Inc.1991-09-13
WELLCOLEX COLOUR SALMONELLA TEST ZL 50 (K890146)Wellcome Diagnostics1989-02-16
BACTIGEN SALMONELLA-SHIGELLA TEST (K870813)Armkel, LLC1987-04-22
SALMONELLA I.D. (K821338)Analytical Products, Inc.1982-05-28

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Every clearance here is in the API, with alerts when new ones post.