Osom Strep a Test
FDA 510(k) K961423 · Wyntek Diagnostics, Inc.
510(k) numberK961423
Submission
- Device name
- Osom Strep a Test
- Applicant
- Wyntek Diagnostics, Inc.
San Diego, CA, US - Received
- April 12, 1996
- Decision date
- October 11, 1996
- 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
| 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 |
| 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 |
| K960712 | Binax Strep a TestGTZ · Traditional | Binax, Inc. | 03/22/1996SE |
More from Binax, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992658 | Osom Ultra Strep a Test, Model 147GTY · Traditional | 01/18/2000SE |
| K990578 | Osom Card II Hcg-Urine Test, Model 102JHI · Traditional | 03/09/1999SE |
| K990576 | Osom Card Pregnancy Test, Model 103LCX · Traditional | 03/09/1999SE |
| K974159 | Osom Hcg-Urine Test Model 101JHI · Traditional | 12/24/1997SE |
| K973879 | Osom Card Hcg-Urine TestJHI · Traditional | 11/04/1997SE |
| K972231 | Osom Mono Test 143KTN · Traditional | 08/26/1997SE |
| K965227 | Osom Classic Hcg-Urine Test (115)JHI · Traditional | 02/04/1997SE |
| K965184 | Perfecta Pregnancy TestLCX · Traditional | 02/04/1997SE |
| K955141 | Osom HCG Combo TestJJX · Traditional | 12/06/1995SE |
| K954178 | Osom Pregnancy TestLCX · Traditional | 10/23/1995SE |
Questions and answers
When was Osom Strep a Test cleared by the FDA?
Osom Strep a Test (K961423) received a 510(k) decision of Substantially Equivalent on October 11, 1996, 182 days after the submission was received.
What is the product code of K961423?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.