GONORRHEA TRANSETTE 1 & 3— 510(k) K831579
Substantially EquivalentSpectrum Diagnostic, Inc.
FDA 510(k) clearance K831579 for GONORRHEA TRANSETTE 1 & 3, Substantially Equivalent on 1983-06-17. Applicant: Spectrum Diagnostic, Inc.. Device class: 1.
Clearance details
- Applicant
- Spectrum Diagnostic, Inc.
- Product code
- Code JTW
- Device class
- Class 1
- Regulation
- 21 CFR 866.2900
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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