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FDA 510(k)

ABACUS 5

K-Number: K112755 · 2012-03-27

ApplicantDiatron U.S., Inc.
Decision Date2012-03-27
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABACUS 5 is the device name listed in this FDA 510(k) record. The listed applicant is Diatron U.S., Inc.. It received FDA 510(k) clearance on 2012-03-27 under 510(k) number K112755. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABACUS 5?

ABACUS 5 is a medical device that received FDA 510(k) clearance on 2012-03-27. The listed applicant is Diatron U.S., Inc.. The 510(k) number is K112755.

When did ABACUS 5 receive FDA 510(k) clearance?

ABACUS 5 received FDA 510(k) clearance on 2012-03-27, under 510(k) number K112755.

Who is the listed applicant for ABACUS 5?

The FDA 510(k) record lists Diatron U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABACUS 5?

The FDA product code for ABACUS 5 is GKZ.

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Other records listing Diatron U.S., 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.

K151487Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase MethodK111534ABACUS 3CP

Related Devices (Code: GKZ)

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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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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