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FDA 510(k)

Access hsTnl

K-Number: K172787 · 2018-06-14

ApplicantBeckman Coulter, Inc.
Decision Date2018-06-14
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access hsTnl is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K172787. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access hsTnl?

Access hsTnl is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K172787.

When did Access hsTnl receive FDA 510(k) clearance?

Access hsTnl received FDA 510(k) clearance on 2018-06-14, under 510(k) number K172787.

Who is the listed applicant for Access hsTnl?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Access hsTnl?

The FDA product code for Access hsTnl is MMI.

Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: MMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.

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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