RUBELLACOL— 510(k) K031490
Substantially EquivalentImmunostics Inc.,
FDA 510(k) clearance K031490 for RUBELLACOL, Substantially Equivalent on 2003-07-16. Applicant: Immunostics Inc.,. Device class: 2.
Clearance details
- Applicant
- Immunostics Inc.,
- Product code
- Code LQN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3510
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ocean, NJ, US
Recent devices under product code LQN
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