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FDA 510(k)

GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT

K-Number: K761089 · 1977-01-25

ApplicantBeckman Instruments, Inc.
Decision Date1977-01-25
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE ANALYZER W/ CHOLESTEROL REAG 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 1977-01-25 under 510(k) number K761089. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT?

GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT is a medical device that received FDA 510(k) clearance on 1977-01-25. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K761089.

When did GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT receive FDA 510(k) clearance?

GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT received FDA 510(k) clearance on 1977-01-25, under 510(k) number K761089.

Who is the listed applicant for GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT?

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

What is the FDA product code for GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT?

The FDA product code for GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT is CHH.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: CHH)

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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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