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FDA 510(k)

SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE

K-Number: K884184 · 1989-03-28

ApplicantSigma Diagnostics, Inc.
Decision Date1989-03-28
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-03-28 under 510(k) number K884184. 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 SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE?

SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE is a medical device that received FDA 510(k) clearance on 1989-03-28. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K884184.

When did SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE receive FDA 510(k) clearance?

SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE received FDA 510(k) clearance on 1989-03-28, under 510(k) number K884184.

Who is the listed applicant for SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE?

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

What is the FDA product code for SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE?

The FDA product code for SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE 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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