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FDA 510(k)

REAGENT FOR DETERM. GLUCOSE IN H/SERUM

K-Number: K800687 · 1980-05-28

ApplicantDiagnostic Solutions, Inc.
Decision Date1980-05-28
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT FOR DETERM. GLUCOSE IN H/SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800687. 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 REAGENT FOR DETERM. GLUCOSE IN H/SERUM?

REAGENT FOR DETERM. GLUCOSE IN H/SERUM is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K800687.

When did REAGENT FOR DETERM. GLUCOSE IN H/SERUM receive FDA 510(k) clearance?

REAGENT FOR DETERM. GLUCOSE IN H/SERUM received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800687.

Who is the listed applicant for REAGENT FOR DETERM. GLUCOSE IN H/SERUM?

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

What is the FDA product code for REAGENT FOR DETERM. GLUCOSE IN H/SERUM?

The FDA product code for REAGENT FOR DETERM. GLUCOSE IN H/SERUM is CGA.

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Other records listing Diagnostic Solutions, 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.

K934892RELIEF PLUS ONE REAGENT STRIP MODIFICATIONK924398UNI-CHECK REAGENT STRIPK921825QUICK-CHECK II REAGENT STRIPK800689REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-K800681REAGENTS FOR DETERM. CO2 IN HUMAN SERUMK800691REAGENT FOR DETERM. LACTATE/DEHYDROGENAS

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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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