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FDA 510(k)

QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS

K-Number: K042446 · 2004-11-02

ApplicantBio-Rad Laboratories, Inc.
Decision Date2004-11-02
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2004-11-02 under 510(k) number K042446. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS?

QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS is a medical device that received FDA 510(k) clearance on 2004-11-02. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K042446.

When did QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS receive FDA 510(k) clearance?

QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS received FDA 510(k) clearance on 2004-11-02, under 510(k) number K042446.

Who is the listed applicant for QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS?

The FDA product code for QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS is JJW.

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Related Devices (Code: JJW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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