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FDA 510(k)

GLUCOMETER-E

K-Number: K863102 · 1986-11-24

ApplicantJ. D. Assoc.
Decision Date1986-11-24
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOMETER-E is the device name listed in this FDA 510(k) record. The listed applicant is J. D. Assoc.. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K863102. 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 GLUCOMETER-E?

GLUCOMETER-E is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is J. D. Assoc.. The 510(k) number is K863102.

When did GLUCOMETER-E receive FDA 510(k) clearance?

GLUCOMETER-E received FDA 510(k) clearance on 1986-11-24, under 510(k) number K863102.

Who is the listed applicant for GLUCOMETER-E?

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

What is the FDA product code for GLUCOMETER-E?

The FDA product code for GLUCOMETER-E is CGA.

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Other records listing J. D. Assoc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K863054AST S.C.E. (GOT)K863103PEG 6,000K863069MAGNESIOMETERK863079CREATINKINETICK863112PROTEINMETERK863053ALT S.C.E. (GPT)

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Related Devices (Code: CGA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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