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FDA 510(k)

QCA ENZYMATIC CHOLESTEROL

K-Number: K853871 · 1985-10-04

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1985-10-04
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QCA ENZYMATIC CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1985-10-04 under 510(k) number K853871. 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 QCA ENZYMATIC CHOLESTEROL?

QCA ENZYMATIC CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1985-10-04. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K853871.

When did QCA ENZYMATIC CHOLESTEROL receive FDA 510(k) clearance?

QCA ENZYMATIC CHOLESTEROL received FDA 510(k) clearance on 1985-10-04, under 510(k) number K853871.

Who is the listed applicant for QCA ENZYMATIC CHOLESTEROL?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QCA ENZYMATIC CHOLESTEROL?

The FDA product code for QCA ENZYMATIC CHOLESTEROL is CHH.

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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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