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FDA 510(k)

FRUCTOSAMINE ABG21 TEST SYSTEM

K-Number: K913614 · 1991-12-02

ApplicantBoehringer Mannheim Corp.
Decision Date1991-12-02
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FRUCTOSAMINE ABG21 TEST SYSTEM 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 1991-12-02 under 510(k) number K913614. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRUCTOSAMINE ABG21 TEST SYSTEM?

FRUCTOSAMINE ABG21 TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1991-12-02. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K913614.

When did FRUCTOSAMINE ABG21 TEST SYSTEM receive FDA 510(k) clearance?

FRUCTOSAMINE ABG21 TEST SYSTEM received FDA 510(k) clearance on 1991-12-02, under 510(k) number K913614.

Who is the listed applicant for FRUCTOSAMINE ABG21 TEST SYSTEM?

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 FRUCTOSAMINE ABG21 TEST SYSTEM?

The FDA product code for FRUCTOSAMINE ABG21 TEST SYSTEM is LCP.

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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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