510(k) K895461
- Device
- WELLCOLEX COLOUR SHIGELLA TEST ZC51
- Applicant
- WELLCOME DIAGNOSTICS
- 510(k) number
- K895461
- Product code
- GNB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-01-11
- Date received
- 1989-09-06
- Regulation
- 866.3660
- Classification name
- Antisera, All Types, Shigella Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- J ROSENBERG
- Address
- 3030 Cornwallis Rd. Research Triangle Pk NC US 27709 27709
FDA Registration Numbers#
- 8020667
- 1119779
- 3003750284
- 3004569406
- 3026312356
- 1025402
- 8010383
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GNB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961537 | SAS SHIGELLA SONNEI FORM II ANTISERUM | Sa Scientific, Inc. | 1996-05-31 |
| K961546 | SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961533 | SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961534 | SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) | Sa Scientific, Inc. | 1996-05-20 |
| K961535 | SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961538 | SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961539 | SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961540 | SAS SHIGELLA SONNEI GROUP D ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961541 | SAS SHIGELLA BOYDII TYPE 8 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961542 | SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961543 | SAS SHIGELLA BOYDII TYPE 9 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961532 | SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961547 | SAS SHIGELLA BOYDII TYPE 14 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961548 | SAS SHIGELLA BOYDII TYPE 15 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
| K961549 | SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM | Sa Scientific, Inc. | 1996-05-20 |
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