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FDA 510(k)

SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.

K-Number: K801422 · 1980-07-08

ApplicantSandare Chemical Co., Inc.
Decision Date1980-07-08
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. 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 1980-07-08 under 510(k) number K801422. 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 LYOPHILIZED GLYCOHEMOGLOBIN CLS.?

SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K801422.

When did SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. receive FDA 510(k) clearance?

SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801422.

Who is the listed applicant for SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.?

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 LYOPHILIZED GLYCOHEMOGLOBIN CLS.?

The FDA product code for SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. is LCP.

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

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Related Devices (Code: LCP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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