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FDA 510(k)

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls

K-Number: K170652 · 2017-06-01

ApplicantFisher Diagnostics
Decision Date2017-06-01
Product CodePRI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls is a medical device manufactured by Fisher Diagnostics. It received FDA 510(k) clearance on 2017-06-01 under approval number K170652. The device is classified under product code PRI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls?

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls is a medical device that received FDA 510(k) clearance on 2017-06-01. It is manufactured by Fisher Diagnostics. The 510(k) number is K170652.

When was ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls approved by the FDA?

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls received FDA 510(k) clearance on 2017-06-01, under approval number K170652.

What company makes ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls?

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls is manufactured by Fisher Diagnostics.

What is the FDA product code for ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls?

The FDA product code for ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls is PRI.

Related Devices (Code: PRI)

K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setFujirebio Diagnostics,Inc. K171338B R A H M S PCT sensitive KRYPTORBrahms GmbH K162827VIDAS B.R.A.H.M.S. PCT (PCT)bioMerieux, Inc. K173927Elecsys BRAHMS PCTRoche Diagnostics K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersDiaSorin, Inc. K192815Elecsys BRAHMS PCTRoche Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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