SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control— 510(k) K221253
Substantially EquivalentMaine Molecular Quality Controls, Inc.
FDA 510(k) clearance K221253 for SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control, Substantially Equivalent on 2023-02-03. 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
- Traditional
- Location
- Saco, ME, US
Recent devices under product code PMN
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- K230868 — SPOTFIRE® RSP Pos & Neg Controls, 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.