Atlas FDA

GNC

60 FDA 510(k) clearances · Product code

80 daysmedian time to decision
91 days90th percentile
60clearances measured

FDA profile

Official device name
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3550
Medical specialty
Microbiology
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RecordFirmDate
VISTA ANTIGEN SALMONELLA O GROUP C (K972388)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA O GROUP A (K972387)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA H B (K972391)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA H D (K972389)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA H A (K972392)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA H C (K972390)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA O GROUP B (K972386)Lee Laboratories, Inc.1997-08-25
VISTA ANTIGEN SALMONELLA O GROUP D (K972395)Lee Laboratories, Inc.1997-08-25
SAS SPICER-EDWARDS 3 ANTISERUM (K955225)Sa Scientific, Inc.1996-02-13
SAS SPICER-EDWARDS 2 ANTISERUM (K955224)Sa Scientific, Inc.1996-02-13
SAS SPICER-EDWARDS 4 ANTISERUM (K955226)Sa Scientific, Inc.1996-02-13
SAS SPICER-EDWARDS 1 ANTISERUM (K955223)Sa Scientific, Inc.1996-02-13
SAS SPICER-EDWARDS L COMPLEX (K955228)Sa Scientific, Inc.1996-02-13
SAS SPICER-EDWARDS EN COMPLEX ANTISERUM (K955227)Sa Scientific, Inc.1996-02-13
SAS SALMONELLA H FACTOR 5 ANTISERUM (K955212)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H FACTOR 6 ANTISERUM (K955211)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H Z36 ANTISERUM (K955220)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H FACTOR 7 ANTISERUM (K955219)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H A ANTISERUM (K955216)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H E COMPLEX ANTISERUM (K955215)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H POLY D ANTISERUM (K955197)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA E,N,X ANTISERUM (K955214)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H Z38 ANTISERUM (K955221)Sa Scientific, Inc.1996-02-07
SAL SALMONELLA H Q ANTISERUM (K955195)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H 1,2 ANTISERUM (K955217)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H E,N,Z15 ANTISERUM (K955213)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H 1,7 ANTISERUM (K955218)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H POLY E ANTISERUM (K955196)Sa Scientific, Inc.1996-02-07
SAS SALMONELLA H R ANTISERUM (K955194)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H T ANTISERUM (K955192)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H POLY C ANTISERUM (K955198)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H POLY B ANTISERUM (K955199)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H L,Z13 ANTISERUM (K955203)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H L,V ANTISERUM (K955205)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H L,Z40 ANTISERUM (K955202)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H G,M ANTISERUM (K955209)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H X ANTISERUM (K955191)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H L,W ANTISERUM (K955204)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H Z6 ANTISERUM (K955188)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H Y ANTISERUM (K955190)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H I ANTISERUM (K955207)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H S ANTISERUM (K955193)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H Z4, Z23 ANTISERUM (K955187)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H POLY A ANTISERUM (K955200)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H H ANTISERUM (K955208)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H K ANTISERUM (K955206)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H F,G, ANTISERUM (K955210)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H Z29 ANTISERUM (K955186)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H Z ANTISERUM (K955189)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA H,M,T, ANTISERUM (K955201)Sa Scientific, Inc.1996-02-02
SAS SALMONELLA O GROUP B ANTIGEN (K953848)Sa Scientific, Inc.1995-10-26
SAS SALMONELLA O GROUP A ANTIGEN (K953841)Sa Scientific, Inc.1995-10-26
SAS SALMONELLA O GROUP F ANTIGEN (K953843)Sa Scientific, Inc.1995-10-26
SAS SALMONELLA VI ANTIGEN (K953844)Sa Scientific, Inc.1995-10-26
SAS SALMONELLA O GROUP C ANTIGEN (K953846)Sa Scientific, Inc.1995-10-26
SAS SALMONELLA H C ANTIGEN (K953842)Sa Scientific, Inc.1995-10-26
SAS SALMONELLA O GROUP D ANTIGEN (K952142)Sa Scientific, Inc.1995-07-17
IMMUNO/FEBRILE ANTIGENS (K883685)Immunostics Co., Inc.1988-09-28
SALMONELLA FLAGELLAR A ANTIGEN & B (K801693)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-08-27
AGGLUTINOTEST-SALMONELLA (K791450)Volu Sol Medical Industries1979-09-24

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