Strep-Tex
FDA 510(k) K781607 · Burroughs Wellcome Co.
510(k) numberK781607
Submission
- Device name
- Strep-Tex
- Applicant
- Burroughs Wellcome Co.
Mchenry, IL, US - Received
- September 18, 1978
- Decision date
- October 17, 1978
- 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 |
|---|---|---|
| K820069 | Wellcogen Group BGTZ · Traditional | 02/18/1982SE |
| K813508 | Sac-CelKTS · Traditional | 12/29/1981SE |
| K810215 | Dac-Cel HCGJHI · Traditional | 04/17/1981SE |
| K810214 | Dac-Cel DiagnatalJHI · Traditional | 03/06/1981SE |
| K810213 | Dac-Cel TSHJLW · Traditional | 02/10/1981SE |
| K810212 | Dac-Cel T3 UptakeKHQ · Traditional | 02/10/1981SE |
| K791232 | Dac-Cel T3CDP · Traditional | 09/04/1979SE |
| K791231 | Dac-Cel T4CDX · Traditional | 09/04/1979SE |
| K780874 | Thymune-TDDC · Traditional | 06/14/1978SE |
| K780873 | Thymune-MDDC · Traditional | 06/14/1978SE |
Questions and answers
When was Strep-Tex cleared by the FDA?
Strep-Tex (K781607) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 29 days after the submission was received.
What is the product code of K781607?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.