510(k) K910438
- Device
- DIPSTICK SALMONELLA
- Applicant
- AMPCOR, INC.
- 510(k) number
- K910438
- Product code
- GRM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-09-13
- Date received
- 1991-01-31
- Regulation
- 866.3550
- Classification name
- Antisera, All Groups, Salmonella Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND L MILLER
- Address
- 510 Heron Dr., Bldg. 306 P.O. Box 521 Bridgeport NJ US 08014 08014
FDA Registration Numbers#
- 9611882
- 1119779
- 8020667
- 3003750284
- 1050190
- 3004569406
- 8010096
- 1025402
- 8010383
- 3043196750
- 3006440892
- 3005450604
- 2027113
- 1649661
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961967 | SAS SALMONELLA O POLY B ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961948 | SAS SALMONELLA O FACTOR 20 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961949 | SAS SALMONELLA O FACTOR 14 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961950 | SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961951 | SAS SALMONELLA O FACTOR 6 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961952 | SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS | Sa Scientific, Inc. | 1996-06-18 |
| K961953 | SAS SALMONELA H Z24 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961954 | SAS SALMONELLA H Z35 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961955 | SAS SALMONELLA H Z42 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961956 | SAS SALMONELLA H G,M,Q ANTISERMU | Sa Scientific, Inc. | 1996-06-18 |
| K961958 | SAS SALMONELLA H Z4 COMPLEX ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961960 | SAS SALMONELLA H Z4, Z24 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961961 | SAS SALMONELLA H F,G,T ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961962 | SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
| K961963 | SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM | Sa Scientific, Inc. | 1996-06-18 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases