FDA 510(k) Applications for Medical Device Product Code "GNC"
(Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.)

FDA 510(k) Number Applicant Device Name Decision Date
K972392 LEE LABORATORIES, INC. VISTA ANTIGEN SALMONELLA H A 08/25/1997
K972391 LEE LABORATORIES, INC. VISTA ANTIGEN SALMONELLA H B 08/25/1997
K972390 LEE LABORATORIES, INC. VISTA ANTIGEN SALMONELLA H C 08/25/1997
K972389 LEE LABORATORIES, INC. VISTA ANTIGEN SALMONELLA H D 08/25/1997
K972387 LEE LABORATORIES, INC. VISTA ANTIGEN SALMONELLA O GROUP A 08/25/1997
K972386 LEE LABORATORIES, INC. VISTA ANTIGEN SALMONELLA O GROUP B 08/25/1997
K972388 LEE LABORATORIES, INC. VISTA ANTIGEN SALMONELLA O GROUP C 08/25/1997
K972395 LEE LABORATORIES, INC. VISTA ANTIGEN SALMONELLA O GROUP D 08/25/1997
K955195 SA SCIENTIFIC, INC. SAL SALMONELLA H Q ANTISERUM 02/07/1996
K955214 SA SCIENTIFIC, INC. SAS SALMONELLA E,N,X ANTISERUM 02/07/1996
K955217 SA SCIENTIFIC, INC. SAS SALMONELLA H 1,2 ANTISERUM 02/07/1996
K955218 SA SCIENTIFIC, INC. SAS SALMONELLA H 1,7 ANTISERUM 02/07/1996
K955216 SA SCIENTIFIC, INC. SAS SALMONELLA H A ANTISERUM 02/07/1996
K955215 SA SCIENTIFIC, INC. SAS SALMONELLA H E COMPLEX ANTISERUM 02/07/1996
K955213 SA SCIENTIFIC, INC. SAS SALMONELLA H E,N,Z15 ANTISERUM 02/07/1996
K955210 SA SCIENTIFIC, INC. SAS SALMONELLA H F,G, ANTISERUM 02/02/1996
K955212 SA SCIENTIFIC, INC. SAS SALMONELLA H FACTOR 5 ANTISERUM 02/07/1996
K955211 SA SCIENTIFIC, INC. SAS SALMONELLA H FACTOR 6 ANTISERUM 02/07/1996
K955219 SA SCIENTIFIC, INC. SAS SALMONELLA H FACTOR 7 ANTISERUM 02/07/1996
K955209 SA SCIENTIFIC, INC. SAS SALMONELLA H G,M ANTISERUM 02/02/1996
K955208 SA SCIENTIFIC, INC. SAS SALMONELLA H H ANTISERUM 02/02/1996
K955207 SA SCIENTIFIC, INC. SAS SALMONELLA H I ANTISERUM 02/02/1996
K955206 SA SCIENTIFIC, INC. SAS SALMONELLA H K ANTISERUM 02/02/1996
K955205 SA SCIENTIFIC, INC. SAS SALMONELLA H L,V ANTISERUM 02/02/1996
K955204 SA SCIENTIFIC, INC. SAS SALMONELLA H L,W ANTISERUM 02/02/1996
K955203 SA SCIENTIFIC, INC. SAS SALMONELLA H L,Z13 ANTISERUM 02/02/1996
K955202 SA SCIENTIFIC, INC. SAS SALMONELLA H L,Z40 ANTISERUM 02/02/1996
K955200 SA SCIENTIFIC, INC. SAS SALMONELLA H POLY A ANTISERUM 02/02/1996
K955199 SA SCIENTIFIC, INC. SAS SALMONELLA H POLY B ANTISERUM 02/02/1996
K955198 SA SCIENTIFIC, INC. SAS SALMONELLA H POLY C ANTISERUM 02/02/1996
K955197 SA SCIENTIFIC, INC. SAS SALMONELLA H POLY D ANTISERUM 02/07/1996
K955196 SA SCIENTIFIC, INC. SAS SALMONELLA H POLY E ANTISERUM 02/07/1996
K955194 SA SCIENTIFIC, INC. SAS SALMONELLA H R ANTISERUM 02/02/1996
K955193 SA SCIENTIFIC, INC. SAS SALMONELLA H S ANTISERUM 02/02/1996
K955192 SA SCIENTIFIC, INC. SAS SALMONELLA H T ANTISERUM 02/02/1996
K955191 SA SCIENTIFIC, INC. SAS SALMONELLA H X ANTISERUM 02/02/1996
K955190 SA SCIENTIFIC, INC. SAS SALMONELLA H Y ANTISERUM 02/02/1996
K955189 SA SCIENTIFIC, INC. SAS SALMONELLA H Z ANTISERUM 02/02/1996
K955186 SA SCIENTIFIC, INC. SAS SALMONELLA H Z29 ANTISERUM 02/02/1996
K955220 SA SCIENTIFIC, INC. SAS SALMONELLA H Z36 ANTISERUM 02/07/1996
K955221 SA SCIENTIFIC, INC. SAS SALMONELLA H Z38 ANTISERUM 02/07/1996
K955187 SA SCIENTIFIC, INC. SAS SALMONELLA H Z4, Z23 ANTISERUM 02/02/1996
K955188 SA SCIENTIFIC, INC. SAS SALMONELLA H Z6 ANTISERUM 02/02/1996
K955201 SA SCIENTIFIC, INC. SAS SALMONELLA H,M,T, ANTISERUM 02/02/1996
K955223 SA SCIENTIFIC, INC. SAS SPICER-EDWARDS 1 ANTISERUM 02/13/1996
K955224 SA SCIENTIFIC, INC. SAS SPICER-EDWARDS 2 ANTISERUM 02/13/1996
K955225 SA SCIENTIFIC, INC. SAS SPICER-EDWARDS 3 ANTISERUM 02/13/1996
K955226 SA SCIENTIFIC, INC. SAS SPICER-EDWARDS 4 ANTISERUM 02/13/1996
K955227 SA SCIENTIFIC, INC. SAS SPICER-EDWARDS EN COMPLEX ANTISERUM 02/13/1996
K955228 SA SCIENTIFIC, INC. SAS SPICER-EDWARDS L COMPLEX 02/13/1996


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