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FDA 510(k)

KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST

K-Number: K912251 · 1991-07-18

ApplicantKing Diagnostics, Inc.
Decision Date1991-07-18
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP 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 1991-07-18 under 510(k) number K912251. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST?

KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST is a medical device that received FDA 510(k) clearance on 1991-07-18. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K912251.

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

KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST received FDA 510(k) clearance on 1991-07-18, under 510(k) number K912251.

Who is the listed applicant for KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP 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 (HK) REAGENT STRIP TEST?

The FDA product code for KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST is CFR.

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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: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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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