Detect-A-Strep
FDA 510(k) K843590 · Antibodies, Inc.
510(k) numberK843590
Submission
- Device name
- Detect-A-Strep
- Applicant
- Antibodies, Inc.
Davis, CA, US - Received
- September 12, 1984
- Decision date
- October 30, 1984
- 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.
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|---|---|---|
| K890774 | Giardeia(Tm)KHW · Traditional | 04/04/1989SE |
| K822892 | Cortisol Ria KitCGR · Traditional | 11/01/1982SE |
| K812749 | Ultra-DigLCS · Traditional | 10/19/1981SE |
| K812314 | Crithidna Anti-Dna Test KitDHN · Traditional | 09/01/1981SE |
| K802877 | Amikacin Ria KitKLQ · Traditional | 12/19/1980SE |
| K800743 | Tobramycin Ria KitKLB · Traditional | 04/16/1980SE |
| K791217 | TSH Ria KitJLW · Traditional | 09/04/1979SE |
| K781656 | Nephelrate Antiserums, IggCFN · Traditional | 11/08/1978SE |
| K781655 | Nephelrate Antiserums 1GACFN · Traditional | 11/08/1978SE |
| K781654 | Nephelrate Antiperums LGMCFN · Traditional | 11/08/1978SE |
Questions and answers
When was Detect-A-Strep cleared by the FDA?
Detect-A-Strep (K843590) received a 510(k) decision of Substantially Equivalent on October 30, 1984, 48 days after the submission was received.
What is the product code of K843590?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.