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FDA 510(k)

GDH-GLUCOSE (RATE) REAGENT KIT

K-Number: K770062 · 1977-01-26

ApplicantBeckman Instruments, Inc.
Decision Date1977-01-26
Product Code
DecisionSubstantially Equivalent

Device Summary

GDH-GLUCOSE (RATE) REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1977-01-26 under 510(k) number K770062. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GDH-GLUCOSE (RATE) REAGENT KIT?

GDH-GLUCOSE (RATE) REAGENT KIT is a medical device that received FDA 510(k) clearance on 1977-01-26. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K770062.

When did GDH-GLUCOSE (RATE) REAGENT KIT receive FDA 510(k) clearance?

GDH-GLUCOSE (RATE) REAGENT KIT received FDA 510(k) clearance on 1977-01-26, under 510(k) number K770062.

Who is the listed applicant for GDH-GLUCOSE (RATE) REAGENT KIT?

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

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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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