INTROL CF PANEL I CONTROL, MODEL: G106— 510(k) K083171
Substantially EquivalentMaine Molecular Quality Controls, Inc.
FDA 510(k) clearance K083171 for INTROL CF PANEL I CONTROL, MODEL: G106, Substantially Equivalent on 2008-12-16. Applicant: Maine Molecular Quality Controls, Inc.. Device class: 2.
Clearance details
- Applicant
- Maine Molecular Quality Controls, Inc.
- Product code
- Code NZB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5910
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scarborough, ME, US
Recent devices under product code NZB
view allMore clearances from Maine Molecular Quality Controls, Inc.
view all- K260577 — FilmArray TF Control Panel M527
- K251526 — FilmArray GI Control Panel M238
- K241289 — SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
- K233611 — SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
- K230868 — SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
Data sourced from openFDA. This site is unofficial and independent of the FDA.