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BioFire RP2.1/RP2.1plus Control Panel M441

by Maine Molecular Quality Controls, Inc.

510(k) K202196

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202196 Date24 Jun 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PMN
Device Class
Class II
Regulation
21 CFR Part 866.3920
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

From the manufacturer

Manufacturer's product page: eplex RP2 Control M451

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