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FDA 510(k)

REFLOTRON POTASSIUM TEST TABS

K-Number: K904033 · 1990-11-06

ApplicantBoehringer Mannheim Corp.
Decision Date1990-11-06
Product CodeCEJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFLOTRON POTASSIUM TEST TABS 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 1990-11-06 under 510(k) number K904033. The device is classified under product code CEJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLOTRON POTASSIUM TEST TABS?

REFLOTRON POTASSIUM TEST TABS is a medical device that received FDA 510(k) clearance on 1990-11-06. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K904033.

When did REFLOTRON POTASSIUM TEST TABS receive FDA 510(k) clearance?

REFLOTRON POTASSIUM TEST TABS received FDA 510(k) clearance on 1990-11-06, under 510(k) number K904033.

Who is the listed applicant for REFLOTRON POTASSIUM TEST TABS?

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 REFLOTRON POTASSIUM TEST TABS?

The FDA product code for REFLOTRON POTASSIUM TEST TABS is CEJ.

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Related Devices (Code: CEJ)

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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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