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FDA 510(k)

ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY

K-Number: K900718 · 1990-06-12

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-06-12
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY 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 1990-06-12 under 510(k) number K900718. 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 ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY?

ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY is a medical device that received FDA 510(k) clearance on 1990-06-12. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K900718.

When did ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY receive FDA 510(k) clearance?

ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY received FDA 510(k) clearance on 1990-06-12, under 510(k) number K900718.

Who is the listed applicant for ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY?

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 ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY?

The FDA product code for ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY is LCP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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