Patho DX Latex Agglutination Strep Grouping Kit
FDA 510(k) K871831 · Diagnostic Products Corp.
510(k) numberK871831
Submission
- Device name
- Patho DX Latex Agglutination Strep Grouping Kit
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- May 11, 1987
- Decision date
- June 17, 1987
- 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
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| 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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Questions and answers
When was Patho DX Latex Agglutination Strep Grouping Kit cleared by the FDA?
Patho DX Latex Agglutination Strep Grouping Kit (K871831) received a 510(k) decision of Substantially Equivalent on June 17, 1987, 37 days after the submission was received.
What is the product code of K871831?
The FDA product code is GTZ – Antisera, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.