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FDA 510(k)

AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER

K-Number: K854028 · 1985-12-02

ApplicantVerified Medical Research, Inc.
Decision Date1985-12-02
Product CodeJIW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Verified Medical Research, Inc.. It received FDA 510(k) clearance on 1985-12-02 under 510(k) number K854028. The device is classified under product code JIW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER?

AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1985-12-02. The listed applicant is Verified Medical Research, Inc.. The 510(k) number is K854028.

When did AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER receive FDA 510(k) clearance?

AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER received FDA 510(k) clearance on 1985-12-02, under 510(k) number K854028.

Who is the listed applicant for AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER?

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

What is the FDA product code for AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER?

The FDA product code for AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER is JIW.

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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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