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FDA 510(k)

GLUCOSTIX REAGENT STRIPS

K-Number: K926362 · 1993-11-10

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-11-10
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSTIX REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1993-11-10 under 510(k) number K926362. 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 GLUCOSTIX REAGENT STRIPS?

GLUCOSTIX REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1993-11-10. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K926362.

When did GLUCOSTIX REAGENT STRIPS receive FDA 510(k) clearance?

GLUCOSTIX REAGENT STRIPS received FDA 510(k) clearance on 1993-11-10, under 510(k) number K926362.

Who is the listed applicant for GLUCOSTIX REAGENT STRIPS?

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

What is the FDA product code for GLUCOSTIX REAGENT STRIPS?

The FDA product code for GLUCOSTIX REAGENT STRIPS is CGA.

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Other records listing Heraeus Kulzer, Inc. 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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