Exoenzymes, Multiple, Streptococcal
Exoenzymes, Multiple, Streptococcal is a panel of streptococcal exoenzyme reagents used in laboratory testing to measure antibody responses to multiple streptococcal exoenzymes, aiding in the diagnosis of recent streptococcal infections and associated conditions such as rheumatic fever and glomerulonephritis. It is an FDA Class 1 device, requiring only general controls and no premarket submission. The product code is GTP, regulated under 21 CFR 866.3720 in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GTP
- Device Class
- FDA class 1
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K860041 | STREP D FLUOR | Jan 24, 1986 | Substantially Equivalent | Bio Spec, Inc. |
| K833738 | LEAP STREP TEST KIT | Dec 27, 1983 | Substantially Equivalent | Cooper Biomedical, Inc. |
| K822799 | STREPTACOCCUS CO-AGGLUTINATION KIT | Dec 19, 1982 | Substantially Equivalent | American Scientific Products |