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FDA 510(k)

FAST HEMOGLOBIN CONTROL-LYOPHILIZED

K-Number: K800794 · 1980-04-29

ApplicantIsolab, Inc.
Decision Date1980-04-29
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FAST HEMOGLOBIN CONTROL-LYOPHILIZED is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1980-04-29 under 510(k) number K800794. 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 FAST HEMOGLOBIN CONTROL-LYOPHILIZED?

FAST HEMOGLOBIN CONTROL-LYOPHILIZED is a medical device that received FDA 510(k) clearance on 1980-04-29. The listed applicant is Isolab, Inc.. The 510(k) number is K800794.

When did FAST HEMOGLOBIN CONTROL-LYOPHILIZED receive FDA 510(k) clearance?

FAST HEMOGLOBIN CONTROL-LYOPHILIZED received FDA 510(k) clearance on 1980-04-29, under 510(k) number K800794.

Who is the listed applicant for FAST HEMOGLOBIN CONTROL-LYOPHILIZED?

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

What is the FDA product code for FAST HEMOGLOBIN CONTROL-LYOPHILIZED?

The FDA product code for FAST HEMOGLOBIN CONTROL-LYOPHILIZED 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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