V-Trend Strep a Test
FDA 510(k) K880483 · Texas Immunology, Inc.
510(k) numberK880483
Submission
- Device name
- V-Trend Strep a Test
- Applicant
- Texas Immunology, Inc.
Tyler, TX, US - Received
- February 5, 1988
- Decision date
- April 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GTZ – Antisera, All Groups, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
Other 510(k)s with product code GTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012521 | Binax Now Streptococcus Pneumoniae TestGTZ · Traditional | Binax, Inc. | 11/30/2001SE |
| K011709 | Uni-Gold Strep a Test KitGTZ · Traditional | Trinity Biotech, Plc | 11/08/2001SE |
| K010523 | Modification to Binax Now Streptococcus Pneumoniae Urinary Antigen TestGTZ · Special | Binax, Inc. | 03/15/2001SE |
| K991726 | Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test KIT),(12 Test Kit)…GTZ · Traditional | Binax, Inc. | 08/27/1999SE |
| K971522 | Abbott Testpack Plus Strep a with on Board Controls (Obc) IIGTZ · Traditional | Abbott Laboratories | 03/03/1998SE |
| K962060 | Strep a Oia MaxGTZ · Traditional | Biostar, Inc. | 07/23/1997SE |
| K962296 | Streptolex-StatGTZ · Traditional | Unipath , Ltd. | 12/16/1996SE |
| K961423 | Osom Strep a TestGTZ · Traditional | Wyntek Diagnostics, Inc. | 10/11/1996SE |
| K962146 | Excel Onestep Group a Strep Antigen Module Test KitGTZ · Traditional | Excel Scientific, Inc. | 10/07/1996SE |
| K955108 | Cards Q.S. Strep aGTZ · Traditional | Quidel Corp. | 04/15/1996SE |
More from Quidel Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K991465 | Drug StopMVO · Traditional | 12/10/1999SE |
| K980153 | Drug CheckDIO · Traditional | 03/27/1998SE |
| K973208 | First SignLCX · Traditional | 10/20/1997SE |
| K972094 | Target Cardiac Troponin I TestMMI · Traditional | 07/23/1997SE |
| K963680 | Target Myoglobin TestDDR · Traditional | 02/06/1997SE |
| K912246 | Target Microalbuminuria TestJIR · Traditional | 07/19/1991SE |
| K910073 | Target Aso TestGTQ · Traditional | 05/21/1991SE |
| K904105 | V-Trend Target RF TestDHR · Traditional | 10/15/1990SE |
| K892231 | V-Trend Target CRP TestDCN · Traditional | 04/21/1989SE |
| K890423 | V-Trend Target CRP TestDCK · Traditional | 02/17/1989SE |
Questions and answers
When was V-Trend Strep a Test cleared by the FDA?
V-Trend Strep a Test (K880483) received a 510(k) decision of Substantially Equivalent on April 12, 1988, 67 days after the submission was received.
What is the product code of K880483?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.