DeviceClearance

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control— 510(k) K221253

Substantially Equivalent

Maine 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..

Clearance details

Applicant
Maine Molecular Quality Controls, Inc.
Product code
Code PMN
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Saco, ME, US
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