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FDA 510(k)

CHOLESTEROL CALIBRATOR

K-Number: K761197 · 1976-12-21

ApplicantBeckman Instruments, Inc.
Decision Date1976-12-21
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL CALIBRATOR 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 1976-12-21 under 510(k) number K761197. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLESTEROL CALIBRATOR?

CHOLESTEROL CALIBRATOR is a medical device that received FDA 510(k) clearance on 1976-12-21. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K761197.

When did CHOLESTEROL CALIBRATOR receive FDA 510(k) clearance?

CHOLESTEROL CALIBRATOR received FDA 510(k) clearance on 1976-12-21, under 510(k) number K761197.

Who is the listed applicant for CHOLESTEROL CALIBRATOR?

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 CHOLESTEROL CALIBRATOR?

The FDA product code for CHOLESTEROL CALIBRATOR is JIT.

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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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