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FDA 510(k)

THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE

K-Number: K012943 · 2002-01-18

ApplicantQuantech , Ltd.
Decision Date2002-01-18
Product CodeNAL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Quantech , Ltd.. It received FDA 510(k) clearance on 2002-01-18 under 510(k) number K012943. The device is classified under product code NAL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE?

THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is Quantech , Ltd.. The 510(k) number is K012943.

When did THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE receive FDA 510(k) clearance?

THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE received FDA 510(k) clearance on 2002-01-18, under 510(k) number K012943.

Who is the listed applicant for THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE?

The FDA 510(k) record lists Quantech , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE?

The FDA product code for THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE is NAL.

Related Clinical Trials

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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Other records listing Quantech , Ltd. as applicant

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.

K990258QUANTECH TOTAL B-HCG ASSAYK984433QUANTECH CK-MB ASSAY

Related Devices (Code: NAL)

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.

K990258QUANTECH TOTAL B-HCG ASSAYQuantech , Ltd.

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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