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FDA 510(k)

BIOLIS 12I

K-Number: K110520 · 2012-03-23

ApplicantTokyo Boeki Medisys, Inc.
Decision Date2012-03-23
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOLIS 12I is the device name listed in this FDA 510(k) record. The listed applicant is Tokyo Boeki Medisys, Inc.. It received FDA 510(k) clearance on 2012-03-23 under 510(k) number K110520. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLIS 12I?

BIOLIS 12I is a medical device that received FDA 510(k) clearance on 2012-03-23. The listed applicant is Tokyo Boeki Medisys, Inc.. The 510(k) number is K110520.

When did BIOLIS 12I receive FDA 510(k) clearance?

BIOLIS 12I received FDA 510(k) clearance on 2012-03-23, under 510(k) number K110520.

Who is the listed applicant for BIOLIS 12I?

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

What is the FDA product code for BIOLIS 12I?

The FDA product code for BIOLIS 12I is CEM.

Related Clinical Trials

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.

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Other records listing Tokyo Boeki Medisys, Inc. as applicant

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.

K103531PRESTIGE 24I; BIOLIS 24I; MGC 240

Related Devices (Code: CEM)

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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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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