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FDA 510(k)

GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET

K-Number: K860572 · 1986-05-16

ApplicantPointe Scientific, Inc.,
Decision Date1986-05-16
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1986-05-16 under 510(k) number K860572. 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 GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET?

GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-05-16. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K860572.

When did GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET receive FDA 510(k) clearance?

GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET received FDA 510(k) clearance on 1986-05-16, under 510(k) number K860572.

Who is the listed applicant for GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET?

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

What is the FDA product code for GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET?

The FDA product code for GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET 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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