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FDA 510(k)

COBAS READY CHOLESTEROL REAGENT

K-Number: K896239 · 1990-02-16

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-02-16
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS READY CHOLESTEROL REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K896239. 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 COBAS READY CHOLESTEROL REAGENT?

COBAS READY CHOLESTEROL REAGENT is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K896239.

When did COBAS READY CHOLESTEROL REAGENT receive FDA 510(k) clearance?

COBAS READY CHOLESTEROL REAGENT received FDA 510(k) clearance on 1990-02-16, under 510(k) number K896239.

Who is the listed applicant for COBAS READY CHOLESTEROL REAGENT?

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

What is the FDA product code for COBAS READY CHOLESTEROL REAGENT?

The FDA product code for COBAS READY CHOLESTEROL REAGENT 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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