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FDA 510(k)

GILUCOCHEK REFLECTANCE METER

K-Number: K810665 · 1981-04-17

ApplicantLifescan, Inc.
Decision Date1981-04-17
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GILUCOCHEK REFLECTANCE METER is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan, Inc.. It received FDA 510(k) clearance on 1981-04-17 under 510(k) number K810665. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GILUCOCHEK REFLECTANCE METER?

GILUCOCHEK REFLECTANCE METER is a medical device that received FDA 510(k) clearance on 1981-04-17. The listed applicant is Lifescan, Inc.. The 510(k) number is K810665.

When did GILUCOCHEK REFLECTANCE METER receive FDA 510(k) clearance?

GILUCOCHEK REFLECTANCE METER received FDA 510(k) clearance on 1981-04-17, under 510(k) number K810665.

Who is the listed applicant for GILUCOCHEK REFLECTANCE METER?

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

What is the FDA product code for GILUCOCHEK REFLECTANCE METER?

The FDA product code for GILUCOCHEK REFLECTANCE METER is JJQ.

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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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