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FDA 510(k)

KING DIAGNOSTICS GLUCOSE TEST

K-Number: K811882 · 1981-07-23

ApplicantKing Diagnostics, Inc.
Decision Date1981-07-23
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KING DIAGNOSTICS GLUCOSE TEST is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-07-23 under 510(k) number K811882. 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 KING DIAGNOSTICS GLUCOSE TEST?

KING DIAGNOSTICS GLUCOSE TEST is a medical device that received FDA 510(k) clearance on 1981-07-23. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K811882.

When did KING DIAGNOSTICS GLUCOSE TEST receive FDA 510(k) clearance?

KING DIAGNOSTICS GLUCOSE TEST received FDA 510(k) clearance on 1981-07-23, under 510(k) number K811882.

Who is the listed applicant for KING DIAGNOSTICS GLUCOSE TEST?

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

What is the FDA product code for KING DIAGNOSTICS GLUCOSE TEST?

The FDA product code for KING DIAGNOSTICS GLUCOSE TEST is CGA.

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Other records listing King Diagnostics, Inc. 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.

K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENTK931834KING SODIUM/POTASSIUM STANDARD MODIFIEDK931773HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)K931326KING DIAGNOSTICS CK REAGENTK923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTK922969KING DIAGNOSTICS UREA NITROGEN REAGENT

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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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