SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control— 510(k) K262573
Substantially EquivalentMaine Molecular Quality Controls, Inc.
FDA 510(k) clearance K262573 for SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control, Substantially Equivalent on 2026-10-21. Applicant: Maine Molecular Quality Controls, Inc.. Device class: 2.
Clearance details
- Applicant
- Maine Molecular Quality Controls, Inc.
- Product code
- Product code PMN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3920
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saco, ME, US
Recent devices under product code PMN
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view all- K251526 — FilmArray GI Control Panel M238
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- 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
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