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FDA 510(k)

MAJOR QUALITY GLUCOSE AND KETONES URINE TEST

K-Number: K870500 · 1987-03-06

ApplicantAmerican Diagnostic Corp.
Decision Date1987-03-06
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAJOR QUALITY GLUCOSE AND KETONES URINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1987-03-06 under 510(k) number K870500. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAJOR QUALITY GLUCOSE AND KETONES URINE TEST?

MAJOR QUALITY GLUCOSE AND KETONES URINE TEST is a medical device that received FDA 510(k) clearance on 1987-03-06. The listed applicant is American Diagnostic Corp.. The 510(k) number is K870500.

When did MAJOR QUALITY GLUCOSE AND KETONES URINE TEST receive FDA 510(k) clearance?

MAJOR QUALITY GLUCOSE AND KETONES URINE TEST received FDA 510(k) clearance on 1987-03-06, under 510(k) number K870500.

Who is the listed applicant for MAJOR QUALITY GLUCOSE AND KETONES URINE TEST?

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

What is the FDA product code for MAJOR QUALITY GLUCOSE AND KETONES URINE TEST?

The FDA product code for MAJOR QUALITY GLUCOSE AND KETONES URINE TEST is JIL.

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Other records listing American Diagnostic Corp. as applicant

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Related Devices (Code: JIL)

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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