Product Code: GRM
FDA class 2
21 CFR 866.3550
Antisera, All Groups, Salmonella Spp.
Microbiology
The Antisera, All Groups, Salmonella Spp. is a collection of antisera covering all serogroup specificities used in the laboratory serotyping of Salmonella species isolates. As an FDA Class 2 device, it carries moderate risk and requires 510(k) premarket notification to demonstrate substantial equivalence. Regulated under 21 CFR 866.3550 with product code GRM in the Microbiology specialty. No special flags apply to this device.
510(k)s
69
FEI Numbers
14
Registration Numbers
14
Unique Applicants
6
Years Active
14
Research product code GRM in seconds
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Basic Information
- Product Code
- GRM
- 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 69 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K961967 | SAS SALMONELLA O POLY B ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961966 | SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961964 | SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961963 | SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961962 | SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961961 | SAS SALMONELLA H F,G,T ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961960 | SAS SALMONELLA H Z4, Z24 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961958 | SAS SALMONELLA H Z4 COMPLEX ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961957 | SAS SALMONELLA H Z4, Z32 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961956 | SAS SALMONELLA H G,M,Q ANTISERMU | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961955 | SAS SALMONELLA H Z42 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961954 | SAS SALMONELLA H Z35 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961953 | SAS SALMONELA H Z24 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961952 | SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961951 | SAS SALMONELLA O FACTOR 6 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961950 | SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961949 | SAS SALMONELLA O FACTOR 14 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K961948 | SAS SALMONELLA O FACTOR 20 ANTISERUM | Jun 18, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960461 | SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM | Mar 12, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960160 | SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM | Mar 12, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960147 | SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM | Mar 12, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960130 | SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM | Mar 12, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960129 | SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM | Mar 12, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960465 | SAS SALMONELLA O GROUP P FACTOR 38 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960463 | SAS SALMONELLA O GROUP U FACTOR 43 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960462 | SAS SALMONELLA O GROUP Q FACTOR 39 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960460 | SAS SALMONELLA O FACTOR 46 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960459 | SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960458 | SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960163 | SAS SALMONELLA 0 FACTOR FACTOR 5 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960162 | SAS SALMONELLA 0 GROUP 0 FACTOR 35 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960161 | SAS SALMONELLA 0 GROUP N FACTOR 30 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960153 | SAS SALOMNELLA 0 GROUP L FACTOR 21 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960152 | SAS SALMONELLA 0 FACTOR 12 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960150 | SAS SALMONELLA 0 GROUP J FACTOR 17 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960149 | SAS SALMONELLA 0 GROUP F FACTOR 11 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960145 | SAS SALMONELLA 0 FACTOR 27 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960142 | SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0 GROUP G2 FACTOR 23 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960140 | SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C1 FACTOR 7 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960138 | SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C2 FACTOR 9 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960137 | SAS SALMONELLA H Z10 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960136 | SAS SALMONELLA H P ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960135 | SAS SALMONELLA H M ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960134 | SAS SALMONELLA 0 FACTOR 9 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP D FACTOR 9 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960132 | SAS SALMONELLA H U ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960127 | SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O GROUP G1 FACTOR 22 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960126 | SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O GROUP E4 FACTOR 19 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960125 | SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960124 | SAS SALMONELLA 0 FACTOR 10 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP E1 FACTOR 10 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960123 | SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM | Mar 06, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960610 | SAS SALMONELLA H Z15 ANTISERUM | Mar 04, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960609 | SAS SALMONELLA H Z32 ANTISERUM | Mar 04, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960603 | SAS SALMONELLA H Z23 ANTISERUM | Mar 04, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960335 | SAS SALMONELLA H POLY A-Z ANTISERUM | Mar 04, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960333 | SAS SALMONELLA H G,P,U ANTISERUM | Mar 04, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960331 | SAS SALMONELLA H Z28 ANTISERUM | Mar 04, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960133 | SAS SALMONELLA H F ANTISERUM | Mar 04, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K960131 | SAS SALMONELLA H G ANTISERUM | Mar 04, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K955222 | SAS SPICER-EDWARDS 1 COMPLEX | Feb 13, 1996 | Substantially Equivalent | Sa Scientific, Inc. |
| K952288 | SAS SALMONELLA H C ANTISERUM | Jul 25, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K952134 | SAS SALMONELLA H POLY POSITIVE ANTISERUM | Jul 21, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K952133 | SAS SALMONELLA O POLY POSITIVE ANTISERUM | Jul 21, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K951069 | SAS SALMONELLA H B ANTISERUM | Jun 09, 1995 | Substantially Equivalent | Sa Scientific, Inc. |
| K943400 | SAS SALMONELLA H D ANTISERUM | Nov 02, 1994 | Substantially Equivalent | Sa Scientific, Inc. |
| K912791 | SALMONELLA O GROUPING ANTISERA SET | Oct 05, 1992 | Substantially Equivalent | S.M.I. Medical, Inc. |
| K910438 | DIPSTICK SALMONELLA | Sep 13, 1991 | Substantially Equivalent | Ampcor, Inc. |
| K890146 | WELLCOLEX COLOUR SALMONELLA TEST ZL 50 | Feb 16, 1989 | Substantially Equivalent | Wellcome Diagnostics |
| K870813 | BACTIGEN SALMONELLA-SHIGELLA TEST | Apr 22, 1987 | Substantially Equivalent | Armkel, LLC |
| K821338 | SALMONELLA I.D. | May 28, 1982 | Substantially Equivalent | Analytical Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.