Ventrescreen Strep a Test
FDA 510(k) K842239 · Ventrex Laboratories, Inc.
510(k) numberK842239
Submission
- Device name
- Ventrescreen Strep a Test
- Applicant
- Ventrex Laboratories, Inc.
Walker, MI, US - Received
- June 5, 1984
- Decision date
- July 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 |
| K841376 | Wellcogen S. PneumoniaeGWC · Traditional | Wellcome Diagnostics | 05/02/1984SE |
| 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 |
|---|---|---|
| K914554 | Specific Ige Eia-Turbo AssayDHB · Traditional | 03/13/1992SE |
| K913833 | Ventrex Allergen DiscDHB · Traditional | 02/21/1992SE |
| K913434 | Ventrex Coated Tube Intact PTHCEW · Traditional | 10/25/1991SE |
| K905612 | Ventrex Coated Tube Ige RadioimmunoassayDGC · Traditional | 02/21/1991SE |
| K905636 | Ventrex Coated Tube Ige Enzyme ImmunoassayDHB · Traditional | 02/07/1991SE |
| K905247 | SHBG Irma KitCDZ · Traditional | 01/17/1991SE |
| K904330 | Turbo-Rast Specific Ige AssayDHB · Traditional | 12/07/1990SE |
| K903000 | Turbo-Rast Specific Ige AssayJHR · Traditional | 07/31/1990SE |
| K897083 | Ventresign Strep a TestGTZ · Traditional | 01/22/1990SE |
| K895649 | Coated Tube High Sensitivity TSH 200 Uiu/Ml Stan.JIT · Traditional | 01/18/1990SE |
Questions and answers
When was Ventrescreen Strep a Test cleared by the FDA?
Ventrescreen Strep a Test (K842239) received a 510(k) decision of Substantially Equivalent on July 2, 1984, 27 days after the submission was received.
What is the product code of K842239?
The FDA product code is GWC – Antisera, All Types, Streptococcus Pneumoniae, a Class I (low risk) device regulated under 21 CFR 866.3740.