NEISSERIA GONORRHOEAE FLUORO-KIT— 510(k) K800328
Substantially EquivalentClinical Sciences, Inc.
FDA 510(k) clearance K800328 for NEISSERIA GONORRHOEAE FLUORO-KIT, Substantially Equivalent on 1980-03-03. Applicant: Clinical Sciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Sciences, Inc.
- Product code
- Code GTH
- Device class
- Class 2
- Regulation
- 21 CFR 866.3390
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GTH
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