Wellcogen S. Pneumoniae
FDA 510(k) K841376 · Wellcome Diagnostics
510(k) numberK841376
Submission
- Device name
- Wellcogen S. Pneumoniae
- Applicant
- Wellcome Diagnostics
Walker, MI, US - Received
- April 3, 1984
- Decision date
- May 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GWC – Antisera, All Types, Streptococcus Pneumoniae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
Other 510(k)s with product code GWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884966 | Bactigen(R) S. PneumoniaeGWC · Traditional | Armkel, LLC | 02/07/1989SE |
| K884965 | Bactigen(R) Meningitidis PanelGWC · Traditional | Armkel, LLC | 02/07/1989SE |
| K870029 | Immunoscan(Tm) Direct Streptococcus PneumoniaeGWC · Traditional | American Micro Scan | 03/25/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | Lkb Instruments, Inc. | 12/18/1986SE |
| K842239 | Ventrescreen Strep a TestGWC · Traditional | Ventrex Laboratories, Inc. | 07/02/1984SE |
| K831887 | Bactigen S. PneumoniaeGWC · Traditional | Armkel, LLC | 09/26/1983SE |
| K821960 | BBL Pneumoslide TestGWC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/30/1982SE |
| K802337 | Phadebact Pneumococcus TestGWC · Traditional | Pharmacia, Inc. | 10/31/1980SE |
More from Pharmacia, Inc.
| 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 Wellcogen S. Pneumoniae cleared by the FDA?
Wellcogen S. Pneumoniae (K841376) received a 510(k) decision of Substantially Equivalent on May 2, 1984, 29 days after the submission was received.
What is the product code of K841376?
The FDA product code is GWC – Antisera, All Types, Streptococcus Pneumoniae, a Class I (low risk) device regulated under 21 CFR 866.3740.