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FDA 510(k)

ROCHE UNIMATE FRUCTOSAMINE REAGENT

K-Number: K961674 · 1996-09-27

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1996-09-27
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROCHE UNIMATE FRUCTOSAMINE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1996-09-27 under 510(k) number K961674. 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 ROCHE UNIMATE FRUCTOSAMINE REAGENT?

ROCHE UNIMATE FRUCTOSAMINE REAGENT is a medical device that received FDA 510(k) clearance on 1996-09-27. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K961674.

When did ROCHE UNIMATE FRUCTOSAMINE REAGENT receive FDA 510(k) clearance?

ROCHE UNIMATE FRUCTOSAMINE REAGENT received FDA 510(k) clearance on 1996-09-27, under 510(k) number K961674.

Who is the listed applicant for ROCHE UNIMATE FRUCTOSAMINE REAGENT?

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

What is the FDA product code for ROCHE UNIMATE FRUCTOSAMINE REAGENT?

The FDA product code for ROCHE UNIMATE FRUCTOSAMINE REAGENT 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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