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FDA 510(k)

SANDARE GLYCOHEMOGLOBIN PROCEDURE

K-Number: K862556 · 1986-08-08

ApplicantSandare Chemical Co., Inc.
Decision Date1986-08-08
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SANDARE GLYCOHEMOGLOBIN PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Sandare Chemical Co., Inc.. It received FDA 510(k) clearance on 1986-08-08 under 510(k) number K862556. 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 SANDARE GLYCOHEMOGLOBIN PROCEDURE?

SANDARE GLYCOHEMOGLOBIN PROCEDURE is a medical device that received FDA 510(k) clearance on 1986-08-08. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K862556.

When did SANDARE GLYCOHEMOGLOBIN PROCEDURE receive FDA 510(k) clearance?

SANDARE GLYCOHEMOGLOBIN PROCEDURE received FDA 510(k) clearance on 1986-08-08, under 510(k) number K862556.

Who is the listed applicant for SANDARE GLYCOHEMOGLOBIN PROCEDURE?

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

What is the FDA product code for SANDARE GLYCOHEMOGLOBIN PROCEDURE?

The FDA product code for SANDARE GLYCOHEMOGLOBIN PROCEDURE is LCP.

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Other records listing Sandare Chemical Co., Inc. as applicant

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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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