Strep a Oia
FDA 510(k) K915758 · Biosearch Medical Products, Inc.
510(k) numberK915758
Submission
- Device name
- Strep a Oia
- Applicant
- Biosearch Medical Products, Inc.
Boulder, CO, US - Received
- December 23, 1991
- Decision date
- January 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| K944614 | Mega-Brush, Endoscopic Mass Cytology - Celluar Retrieval SystemFDX · Traditional | 04/05/1995SE |
| K932295 | Non-Balloon Replacement Gastrostomy KitKNT · Traditional | 09/08/1994SE |
| K935045 | Biosearch Laproscopic Gastronomy CatheterKNT · Traditional | 08/19/1994SE |
| K923002 | Enteroclysis TubeKNT · Traditional | 06/28/1994SESK |
| K934193 | Cell-Mate(Tm) Mass Cytology-Cellular Retrieval SystEOX · Traditional | 11/19/1993SE |
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Questions and answers
When was Strep a Oia cleared by the FDA?
Strep a Oia (K915758) received a 510(k) decision of Substantially Equivalent on January 30, 1992, 38 days after the submission was received.
What is the product code of K915758?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.