Meningococcus Group B Monoclonal Antibody ZM-51
FDA 510(k) K844762 · Wellcome Diagnostics
510(k) numberK844762
Submission
- Device name
- Meningococcus Group B Monoclonal Antibody ZM-51
- Applicant
- Wellcome Diagnostics
Research Triangle Pk, NC, US - Received
- December 7, 1984
- Decision date
- June 4, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GTJ – Antisera, All Groups, N. Meningitidis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3390
- Specialty
- Microbiology
Other 510(k)s with product code GTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952791 | Directigen Meningitis Combo TestGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/30/1996SE |
| K915330 | Directigen Meningitis Combo Test KitGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/23/1992SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | Vitek Systems, Inc. | 08/12/1991SE |
| K885004 | Bactigen(R) N. MeningitidisGTJ · Traditional | Armkel, LLC | 02/07/1989SE |
| K870089 | Immunoscan(Tm) Direct Neisseria Meningitidis KitGTJ · Traditional | Microscan Div. Baxter Healthcare Corp. | 03/17/1987SE |
| K854852 | Wellcogen Bacterial Antigen KitGTJ · Traditional | Wellcome Diagnostics | 02/04/1986SE |
| K854851 | Wellcogen N. Meningitidis B/E. Coli K1 ZL24GTJ · Traditional | Wellcome Diagnostics | 02/04/1986SE |
| K844999 | Phadebact CSF TestGTJ · Traditional | Pharmacia, Inc. | 10/17/1985SE |
| K851691 | Willcogen Meningitidis Kit ZL25GTJ · Traditional | Wellcome Diagnostics | 06/10/1985SE |
| K844407 | Directigen Neissena Menningitidis Group B TestGTJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/25/1985SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K915203 | D-Dimer Wellcotest (HA10)DAP · Traditional | 01/31/1992SE |
| K910797 | Streptex Acid Extraction KitGTZ · Traditional | 03/29/1991SE |
| K895461 | Wellcolex Colour Shigella Test ZC51GNB · Traditional | 01/11/1990SE |
| 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 |
Questions and answers
When was Meningococcus Group B Monoclonal Antibody ZM-51 cleared by the FDA?
Meningococcus Group B Monoclonal Antibody ZM-51 (K844762) received a 510(k) decision of Substantially Equivalent on June 4, 1985, 179 days after the submission was received.
What is the product code of K844762?
The FDA product code is GTJ – Antisera, All Groups, N. Meningitidis, a Class II (moderate risk) device regulated under 21 CFR 866.3390.