SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control— 510(k) K241289
Substantially EquivalentMaine Molecular Quality Controls, Inc.
FDA 510(k) clearance K241289 for SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control, Substantially Equivalent on 2024-05-30. Applicant: Maine Molecular Quality Controls, Inc.. Device class: 2.
Clearance details
- Applicant
- Maine Molecular Quality Controls, Inc.
- Product code
- Code PMN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3920
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Saco, ME, US
Recent devices under product code PMN
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view all- K251526 — FilmArray GI Control Panel M238
- 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
- K221253 — SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
- K203680 — BioFire JI Control Panel M420
Data sourced from openFDA. This site is unofficial and independent of the FDA.