IMMUNODOT MONO-M TEST— 510(k) K974244
Substantially EquivalentGenbio
FDA 510(k) clearance K974244 for IMMUNODOT MONO-M TEST, Substantially Equivalent on 1998-09-22. Applicant: Genbio. Device class: 1.
Clearance details
- Applicant
- Genbio
- Product code
- Code LSE
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Genbio
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