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FDA 510(k)

HOME BLOOD GLUCOSE MONITOR

K-Number: K822486 · 1982-11-05

ApplicantPharmaquest Corp.
Decision Date1982-11-05
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HOME BLOOD GLUCOSE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaquest Corp.. It received FDA 510(k) clearance on 1982-11-05 under 510(k) number K822486. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOME BLOOD GLUCOSE MONITOR?

HOME BLOOD GLUCOSE MONITOR is a medical device that received FDA 510(k) clearance on 1982-11-05. The listed applicant is Pharmaquest Corp.. The 510(k) number is K822486.

When did HOME BLOOD GLUCOSE MONITOR receive FDA 510(k) clearance?

HOME BLOOD GLUCOSE MONITOR received FDA 510(k) clearance on 1982-11-05, under 510(k) number K822486.

Who is the listed applicant for HOME BLOOD GLUCOSE MONITOR?

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

What is the FDA product code for HOME BLOOD GLUCOSE MONITOR?

The FDA product code for HOME BLOOD GLUCOSE MONITOR is CGA.

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Other records listing Pharmaquest Corp. as applicant

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Related Devices (Code: CGA)

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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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