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FDA 510(k)

FRUCTOSAMINE TEST (ROCHE)

K-Number: K854010 · 1987-12-22

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1987-12-22
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FRUCTOSAMINE TEST (ROCHE) 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 1987-12-22 under 510(k) number K854010. 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 TEST (ROCHE)?

FRUCTOSAMINE TEST (ROCHE) is a medical device that received FDA 510(k) clearance on 1987-12-22. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K854010.

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

FRUCTOSAMINE TEST (ROCHE) received FDA 510(k) clearance on 1987-12-22, under 510(k) number K854010.

Who is the listed applicant for FRUCTOSAMINE TEST (ROCHE)?

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 FRUCTOSAMINE TEST (ROCHE)?

The FDA product code for FRUCTOSAMINE TEST (ROCHE) 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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