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FDA 510(k)

BINAX EQUATE GLYCOHEMOGLOBIN

K-Number: K874749 · 1988-08-12

ApplicantBinax, Inc.
Decision Date1988-08-12
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BINAX EQUATE GLYCOHEMOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 1988-08-12 under 510(k) number K874749. 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 BINAX EQUATE GLYCOHEMOGLOBIN?

BINAX EQUATE GLYCOHEMOGLOBIN is a medical device that received FDA 510(k) clearance on 1988-08-12. The listed applicant is Binax, Inc.. The 510(k) number is K874749.

When did BINAX EQUATE GLYCOHEMOGLOBIN receive FDA 510(k) clearance?

BINAX EQUATE GLYCOHEMOGLOBIN received FDA 510(k) clearance on 1988-08-12, under 510(k) number K874749.

Who is the listed applicant for BINAX EQUATE GLYCOHEMOGLOBIN?

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

What is the FDA product code for BINAX EQUATE GLYCOHEMOGLOBIN?

The FDA product code for BINAX EQUATE GLYCOHEMOGLOBIN 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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