Wellcolex Colour Shigella Test ZC51
FDA 510(k) K895461 · Wellcome Diagnostics
510(k) numberK895461
Submission
- Device name
- Wellcolex Colour Shigella Test ZC51
- Applicant
- Wellcome Diagnostics
Research Triangle Pk, NC, US - Received
- September 6, 1989
- Decision date
- January 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNB – Antisera, All Types, Shigella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3660
- Specialty
- Microbiology
Other 510(k)s with product code GNB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961537 | SAS Shigella Sonnei Form II AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/31/1996SE |
| K961559 | SAS Shigella Dysenteriae Type 9 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961558 | SAS Shigella Flexneri Type 3 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961556 | SAS Shigella Flexneri Type 1 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961554 | SAS Shigella Boydii Type 10 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961553 | SAS Shigella Dysenteriae Type 1 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961551 | SAS Shigella Dysenteriae Type 2 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961549 | SAS Shigella Flexneri Type 2 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961548 | SAS Shigella Boydii Type 15 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
| K961547 | SAS Shigella Boydii Type 14 AntiserumGNB · Traditional | Sa Scientific, Inc. | 05/20/1996SE |
More from Sa Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915203 | D-Dimer Wellcotest (HA10)DAP · Traditional | 01/31/1992SE |
| K910797 | Streptex Acid Extraction KitGTZ · Traditional | 03/29/1991SE |
| K890146 | Wellcolex Colour Salmonella Test ZL 50GRM · Traditional | 02/16/1989SE |
| K875311 | Wellcozyme HSV WZO2GQN · Traditional | 08/03/1988SE |
| K861628 | Wellcozyme Rotavirus WZ01LIQ · Traditional | 01/21/1987SE |
| K864206 | Reveal Colour Strep a ZL16GTZ · Traditional | 01/13/1987SE |
| K861634 | The Wellcome Rotavirus Latex Test ZL40LIQ · Traditional | 10/29/1986SE |
| K854852 | Wellcogen Bacterial Antigen KitGTJ · Traditional | 02/04/1986SE |
| K854851 | Wellcogen N. Meningitidis B/E. Coli K1 ZL24GTJ · Traditional | 02/04/1986SE |
| K851691 | Willcogen Meningitidis Kit ZL25GTJ · Traditional | 06/10/1985SE |
Questions and answers
When was Wellcolex Colour Shigella Test ZC51 cleared by the FDA?
Wellcolex Colour Shigella Test ZC51 (K895461) received a 510(k) decision of Substantially Equivalent on January 11, 1990, 127 days after the submission was received.
What is the product code of K895461?
The FDA product code is GNB – Antisera, All Types, Shigella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3660.