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FDA 510(k)

ISE/K+

K-Number: K912649 · 1991-07-15

ApplicantBoehringer Mannheim Corp.
Decision Date1991-07-15
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISE/K+ is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1991-07-15 under 510(k) number K912649. 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 ISE/K+?

ISE/K+ is a medical device that received FDA 510(k) clearance on 1991-07-15. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K912649.

When did ISE/K+ receive FDA 510(k) clearance?

ISE/K+ received FDA 510(k) clearance on 1991-07-15, under 510(k) number K912649.

Who is the listed applicant for ISE/K+?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISE/K+?

The FDA product code for ISE/K+ is CEM.

Other records listing Boehringer Mannheim Corp. 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.

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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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