Panels › Microbiology › Product code GRM · Class 2
Antisera, All Groups, Salmonella Spp.
Regulation 866.3550
0510(k)s in 12 months (69 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in GRM
| Company | 510(k)s | Recalls |
|---|---|---|
| Sa Scientific, Inc. | 64 | 0 |
| Ampcor, Inc. | 1 | 0 |
| Analytical Products, Inc. | 1 | 0 |
| Armkel, LLC | 1 | 0 |
| Remel Europe Ltd. | 0 | 1 |
| S.M.I. Medical, Inc. | 1 | 0 |
| Wellcome Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 1996 | K960610 | SAS SALMONELLA H Z15 ANTISERUM Sa Scientific, Inc. | GRM |
| Mar 4, 1996 | K960609 | SAS SALMONELLA H Z32 ANTISERUM Sa Scientific, Inc. | GRM |
| Mar 4, 1996 | K960603 | SAS SALMONELLA H Z23 ANTISERUM Sa Scientific, Inc. | GRM |
| Mar 4, 1996 | K960335 | SAS SALMONELLA H POLY A-Z ANTISERUM Sa Scientific, Inc. | GRM |
| Mar 4, 1996 | K960333 | SAS SALMONELLA H G,P,U ANTISERUM Sa Scientific, Inc. | GRM |
| Mar 4, 1996 | K960331 | SAS SALMONELLA H Z28 ANTISERUM Sa Scientific, Inc. | GRM |
| Mar 4, 1996 | K960133 | SAS SALMONELLA H F ANTISERUM Sa Scientific, Inc. | GRM |
| Mar 4, 1996 | K960131 | SAS SALMONELLA H G ANTISERUM Sa Scientific, Inc. | GRM |
| Feb 13, 1996 | K955222 | SAS SPICER-EDWARDS 1 COMPLEX Sa Scientific, Inc. | GRM |
| Jul 25, 1995 | K952288 | SAS SALMONELLA H C ANTISERUM Sa Scientific, Inc. | GRM |
| Jul 21, 1995 | K952134 | SAS SALMONELLA H POLY POSITIVE ANTISERUM Sa Scientific, Inc. | GRM |
| Jul 21, 1995 | K952133 | SAS SALMONELLA O POLY POSITIVE ANTISERUM Sa Scientific, Inc. | GRM |
| Jun 9, 1995 | K951069 | SAS SALMONELLA H B ANTISERUM Sa Scientific, Inc. | GRM |
| Nov 2, 1994 | K943400 | SAS SALMONELLA H D ANTISERUM Sa Scientific, Inc. | GRM |
| Oct 5, 1992 | K912791 | SALMONELLA O GROUPING ANTISERA SET S.M.I. Medical, Inc. | GRM |
| Sep 13, 1991 | K910438 | DIPSTICK SALMONELLA Ampcor, Inc. | GRM |
| Feb 16, 1989 | K890146 | WELLCOLEX COLOUR SALMONELLA TEST ZL 50 Wellcome Diagnostics | GRM |
| Apr 22, 1987 | K870813 | BACTIGEN SALMONELLA-SHIGELLA TEST Armkel, LLC | GRM |
| May 28, 1982 | K821338 | SALMONELLA I.D. Analytical Products, Inc. | GRM |
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