Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GNC — Predicate Candidate Screening
60 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
91 days90th percentile
60clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972388 | VISTA ANTIGEN SALMONELLA O GROUP C | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972387 | VISTA ANTIGEN SALMONELLA O GROUP A | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972391 | VISTA ANTIGEN SALMONELLA H B | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972389 | VISTA ANTIGEN SALMONELLA H D | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972392 | VISTA ANTIGEN SALMONELLA H A | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972390 | VISTA ANTIGEN SALMONELLA H C | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972386 | VISTA ANTIGEN SALMONELLA O GROUP B | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K972395 | VISTA ANTIGEN SALMONELLA O GROUP D | Lee Laboratories, Inc. | 1997-08-25 | 60 | 0 |
| K955225 | SAS SPICER-EDWARDS 3 ANTISERUM | Sa Scientific, Inc. | 1996-02-13 | 91 | 0 |
| K955224 | SAS SPICER-EDWARDS 2 ANTISERUM | Sa Scientific, Inc. | 1996-02-13 | 91 | 0 |
| K955226 | SAS SPICER-EDWARDS 4 ANTISERUM | Sa Scientific, Inc. | 1996-02-13 | 91 | 0 |
| K955223 | SAS SPICER-EDWARDS 1 ANTISERUM | Sa Scientific, Inc. | 1996-02-13 | 91 | 0 |
| K955228 | SAS SPICER-EDWARDS L COMPLEX | Sa Scientific, Inc. | 1996-02-13 | 91 | 0 |
| K955227 | SAS SPICER-EDWARDS EN COMPLEX ANTISERUM | Sa Scientific, Inc. | 1996-02-13 | 91 | 0 |
| K955212 | SAS SALMONELLA H FACTOR 5 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955211 | SAS SALMONELLA H FACTOR 6 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955220 | SAS SALMONELLA H Z36 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955219 | SAS SALMONELLA H FACTOR 7 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955216 | SAS SALMONELLA H A ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955215 | SAS SALMONELLA H E COMPLEX ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955197 | SAS SALMONELLA H POLY D ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955214 | SAS SALMONELLA E,N,X ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955221 | SAS SALMONELLA H Z38 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955195 | SAL SALMONELLA H Q ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955217 | SAS SALMONELLA H 1,2 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955213 | SAS SALMONELLA H E,N,Z15 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955218 | SAS SALMONELLA H 1,7 ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955196 | SAS SALMONELLA H POLY E ANTISERUM | Sa Scientific, Inc. | 1996-02-07 | 85 | 0 |
| K955194 | SAS SALMONELLA H R ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955192 | SAS SALMONELLA H T ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955198 | SAS SALMONELLA H POLY C ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955199 | SAS SALMONELLA H POLY B ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955203 | SAS SALMONELLA H L,Z13 ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955205 | SAS SALMONELLA H L,V ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955202 | SAS SALMONELLA H L,Z40 ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955209 | SAS SALMONELLA H G,M ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955191 | SAS SALMONELLA H X ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955204 | SAS SALMONELLA H L,W ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955188 | SAS SALMONELLA H Z6 ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955190 | SAS SALMONELLA H Y ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955207 | SAS SALMONELLA H I ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955193 | SAS SALMONELLA H S ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955187 | SAS SALMONELLA H Z4, Z23 ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955200 | SAS SALMONELLA H POLY A ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955208 | SAS SALMONELLA H H ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955206 | SAS SALMONELLA H K ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955210 | SAS SALMONELLA H F,G, ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955186 | SAS SALMONELLA H Z29 ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955189 | SAS SALMONELLA H Z ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
| K955201 | SAS SALMONELLA H,M,T, ANTISERUM | Sa Scientific, Inc. | 1996-02-02 | 80 | 0 |
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