FDA 510(k)

REAGENT SET, U.V. ENZMATIC KINETIC, SGOT

K-Number: K781725 · 1978-11-03

Decision Date1978-11-03

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

REAGENT SET, U.V. ENZMATIC KINETIC, SGOT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781725. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT SET, U.V. ENZMATIC KINETIC, SGOT?

REAGENT SET, U.V. ENZMATIC KINETIC, SGOT is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K781725.

When did REAGENT SET, U.V. ENZMATIC KINETIC, SGOT receive FDA 510(k) clearance?

REAGENT SET, U.V. ENZMATIC KINETIC, SGOT received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781725.

Who is the listed applicant for REAGENT SET, U.V. ENZMATIC KINETIC, SGOT?

The FDA 510(k) record lists Medical Analysis Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAGENT SET, U.V. ENZMATIC KINETIC, SGOT?

The FDA product code for REAGENT SET, U.V. ENZMATIC KINETIC, SGOT is CIT.

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Related Devices (Code: CIT)

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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.