Quikstrip Onestep Strep a Test Immunochroma Assau
FDA 510(k) K935475 · Syntron Bioresearch, Inc.
510(k) numberK935475
Submission
- Device name
- Quikstrip Onestep Strep a Test Immunochroma Assau
- Applicant
- Syntron Bioresearch, Inc.
Carlsbad, CA, US - Received
- November 15, 1993
- Decision date
- August 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
|---|---|---|
| K993491 | Quickpac II One Step Opiates TestDJG · Traditional | 10/29/1999SE |
| K993490 | Quickstrip One Step Opiates TestDJG · Traditional | 10/29/1999SE |
| K992990 | Quickpac II One Step Cocaine TestDIO · Traditional | 09/20/1999SE |
| K992748 | Drugcheck X Multidrug Screening DeviceDIO · Traditional | 09/02/1999SE |
| K992207 | Quikstrip One Step Cocaine Assay (Cocaine and Cocaine Metabolite Test SystemDIO · Traditional | 07/22/1999SE |
| K990325 | Quikstrip Dipscan X Multidrug Screening DeviceDKZ · Traditional | 06/24/1999SE |
| K983113 | Besure Plus One-Step Home Ovulation Predictor KitCEP · Traditional | 11/18/1998SE |
| K981292 | Quikpac II One Step Phencyclidine (PCP) TestLCM · Traditional | 05/26/1998SE |
| K981019 | Quikstrip One Step Phencyclidine (PCP) TestLCM · Traditional | 05/07/1998SE |
| K980349 | Quickpac II One Step Barbiturate TestDIS · Traditional | 03/03/1998SE |
Questions and answers
When was Quikstrip Onestep Strep a Test Immunochroma Assau cleared by the FDA?
Quikstrip Onestep Strep a Test Immunochroma Assau (K935475) received a 510(k) decision of Substantially Equivalent on August 30, 1995, 653 days after the submission was received.
What is the product code of K935475?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.