Latex Agglutination Test
FDA 510(k) K851132 · New Horizons Diagnostics Co.
510(k) numberK851132
Submission
- Device name
- Latex Agglutination Test
- Applicant
- New Horizons Diagnostics Co.
Columbia, MD, US - Received
- March 21, 1985
- Decision date
- July 5, 1985
- 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
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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 |
|---|---|---|
| K932622 | Cholera Smart(Tm)GSQ · Traditional | 06/27/1995SE |
| K925190 | PyloriscreenLYR · Traditional | 03/23/1993SE |
| K922432 | CholerascreenGSQ · Traditional | 12/07/1992SE |
| K874761 | Rapid Colorimetric Direct Strep a TestGTZ · Traditional | 02/19/1988SE |
| K871226 | Syphilis Serological ReagentsGMQ · Traditional | 05/28/1987SE |
| K871105 | The Gonogen II Test Kit for Neisseria GonorrhoeaeLIC · Traditional | 05/13/1987SE |
| K862195 | Rapid Bacteriuria Screen (RBS)JXA · Traditional | 06/30/1986SE |
| K821362 | Improved Gono GenLIC · Traditional | 08/04/1982SE |
| K820007 | Neisseria Gonorrhoeae TestLIC · Traditional | 01/29/1982SE |
Questions and answers
When was Latex Agglutination Test cleared by the FDA?
Latex Agglutination Test (K851132) received a 510(k) decision of Substantially Equivalent on July 5, 1985, 106 days after the submission was received.
What is the product code of K851132?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.