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FDA 510(k)

REFLOTRON HEMOGLOBIN TEST TABS

K-Number: K934064 · 1993-12-06

ApplicantBoehringer Mannheim Corp.
Decision Date1993-12-06
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

REFLOTRON HEMOGLOBIN 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 1993-12-06 under 510(k) number K934064. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLOTRON HEMOGLOBIN TEST TABS?

REFLOTRON HEMOGLOBIN TEST TABS is a medical device that received FDA 510(k) clearance on 1993-12-06. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K934064.

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

REFLOTRON HEMOGLOBIN TEST TABS received FDA 510(k) clearance on 1993-12-06, under 510(k) number K934064.

Who is the listed applicant for REFLOTRON HEMOGLOBIN 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 HEMOGLOBIN TEST TABS?

The FDA product code for REFLOTRON HEMOGLOBIN TEST TABS is KHG.

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Other records listing Boehringer Mannheim Corp. as applicant

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Related Devices (Code: KHG)

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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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