Target Strep a
FDA 510(k) K880460 · V-Tech, Inc.
510(k) numberK880460
Submission
- Device name
- Target Strep a
- Applicant
- V-Tech, Inc.
Pomona, CA, US - Received
- February 3, 1988
- Decision date
- March 3, 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 |
|---|---|---|
| K914303 | Target(Tm)-HogJHI · Traditional | 10/11/1991SE |
| K910893 | Target(Tm) Cannabinoids-R TestLDJ · Traditional | 04/03/1991SE |
| K910892 | Target(Tm) Cannabinoids-V TestLDJ · Traditional | 04/03/1991SE |
| K910739 | Target Amphetamine/Methamphetamine-R (Reader Meth)DKZ · Traditional | 03/21/1991SE |
| K910738 | Target Amphetamine/Methamphetamine-V (Visual Meth)DKZ · Traditional | 03/19/1991SE |
| K910123 | Target Cocaine Metabolite-VKLN · Traditional | 03/19/1991SE |
| K910122 | Target Cocaine Metabolite-RKLN · Traditional | 03/19/1991SE |
| K903937 | Target(Tm) Hog One StepJHI · Traditional | 10/22/1990SE |
| K890978 | Target Opiates-RDJG · Traditional | 11/17/1989SE |
| K890979 | Target Opiates-VDJG · Traditional | 10/04/1989SE |
Questions and answers
When was Target Strep a cleared by the FDA?
Target Strep a (K880460) received a 510(k) decision of Substantially Equivalent on March 3, 1988, 29 days after the submission was received.
What is the product code of K880460?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.