Product Code: GNC
FDA class 2
21 CFR 866.3550
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Microbiology
The Febrile Antigens for Salmonella Species (All Groups, Slide and Tube Tests) are agglutination reagents used in the serological diagnosis and typing of Salmonella infections, supporting the investigation of typhoid fever and non-typhoidal salmonellosis. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket clearance. The product code is GNC, regulated under 21 CFR 866.3550 in the Microbiology specialty.
510(k)s
60
FEI Numbers
5
Registration Numbers
5
Unique Applicants
5
Years Active
18
Research product code GNC in seconds
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Basic Information
- Product Code
- GNC
- Device Class
- FDA class 2
- Regulation Number
- 866.3550
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 60 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972395 | VISTA ANTIGEN SALMONELLA O GROUP D | Aug 25, 1997 | Substantially Equivalent | Lee Laboratories, Inc. |
| K972392 | VISTA ANTIGEN SALMONELLA H A | Aug 25, 1997 | Substantially Equivalent | Lee Laboratories, Inc. |
| K972391 | VISTA ANTIGEN SALMONELLA H B | Aug 25, 1997 | Substantially Equivalent | Lee Laboratories, Inc. |
| K972390 | VISTA ANTIGEN SALMONELLA H C | Aug 25, 1997 | Substantially Equivalent | Lee Laboratories, Inc. |
| K972389 | VISTA ANTIGEN SALMONELLA H D | Aug 25, 1997 | Substantially Equivalent | Lee Laboratories, Inc. |
| K972388 | VISTA ANTIGEN SALMONELLA O GROUP C | Aug 25, 1997 | Substantially Equivalent | Lee Laboratories, Inc. |
| K972387 | VISTA ANTIGEN SALMONELLA O GROUP A | Aug 25, 1997 | Substantially Equivalent | Lee Laboratories, Inc. |
| K972386 | VISTA ANTIGEN SALMONELLA O GROUP B | Aug 25, 1997 | Substantially Equivalent | Lee Laboratories, Inc. |
| K955228 | SAS SPICER-EDWARDS L COMPLEX | Feb 13, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955227 | SAS SPICER-EDWARDS EN COMPLEX ANTISERUM | Feb 13, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955226 | SAS SPICER-EDWARDS 4 ANTISERUM | Feb 13, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955225 | SAS SPICER-EDWARDS 3 ANTISERUM | Feb 13, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955224 | SAS SPICER-EDWARDS 2 ANTISERUM | Feb 13, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955223 | SAS SPICER-EDWARDS 1 ANTISERUM | Feb 13, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955221 | SAS SALMONELLA H Z38 ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955220 | SAS SALMONELLA H Z36 ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955219 | SAS SALMONELLA H FACTOR 7 ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955218 | SAS SALMONELLA H 1,7 ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955217 | SAS SALMONELLA H 1,2 ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955216 | SAS SALMONELLA H A ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955215 | SAS SALMONELLA H E COMPLEX ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955214 | SAS SALMONELLA E,N,X ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955213 | SAS SALMONELLA H E,N,Z15 ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955212 | SAS SALMONELLA H FACTOR 5 ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955211 | SAS SALMONELLA H FACTOR 6 ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955197 | SAS SALMONELLA H POLY D ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955196 | SAS SALMONELLA H POLY E ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955195 | SAL SALMONELLA H Q ANTISERUM | Feb 07, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955210 | SAS SALMONELLA H F,G, ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955209 | SAS SALMONELLA H G,M ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955208 | SAS SALMONELLA H H ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955207 | SAS SALMONELLA H I ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955206 | SAS SALMONELLA H K ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955205 | SAS SALMONELLA H L,V ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955204 | SAS SALMONELLA H L,W ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955203 | SAS SALMONELLA H L,Z13 ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955202 | SAS SALMONELLA H L,Z40 ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955201 | SAS SALMONELLA H,M,T, ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955200 | SAS SALMONELLA H POLY A ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955199 | SAS SALMONELLA H POLY B ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955198 | SAS SALMONELLA H POLY C ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955194 | SAS SALMONELLA H R ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955193 | SAS SALMONELLA H S ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955192 | SAS SALMONELLA H T ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955191 | SAS SALMONELLA H X ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955190 | SAS SALMONELLA H Y ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955189 | SAS SALMONELLA H Z ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955188 | SAS SALMONELLA H Z6 ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955187 | SAS SALMONELLA H Z4, Z23 ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955186 | SAS SALMONELLA H Z29 ANTISERUM | Feb 02, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K953848 | SAS SALMONELLA O GROUP B ANTIGEN | Oct 26, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K953846 | SAS SALMONELLA O GROUP C ANTIGEN | Oct 26, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K953844 | SAS SALMONELLA VI ANTIGEN | Oct 26, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K953843 | SAS SALMONELLA O GROUP F ANTIGEN | Oct 26, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K953842 | SAS SALMONELLA H C ANTIGEN | Oct 26, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K953841 | SAS SALMONELLA O GROUP A ANTIGEN | Oct 26, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K952142 | SAS SALMONELLA O GROUP D ANTIGEN | Jul 17, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K883685 | IMMUNO/FEBRILE ANTIGENS | Sep 28, 1988 | Substantially Equivalent | Immunostics Co., Inc. |
| K801693 | SALMONELLA FLAGELLAR A ANTIGEN & B | Aug 27, 1980 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K791450 | AGGLUTINOTEST-SALMONELLA | Sep 24, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.