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FDA 510(k)

QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA

K-Number: K080381 · 2008-06-25

ApplicantQuest Diagnostics, Inc.
Decision Date2008-06-25
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA is the device name listed in this FDA 510(k) record. The listed applicant is Quest Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-06-25 under 510(k) number K080381. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA?

QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA is a medical device that received FDA 510(k) clearance on 2008-06-25. The listed applicant is Quest Diagnostics, Inc.. The 510(k) number is K080381.

When did QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA receive FDA 510(k) clearance?

QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA received FDA 510(k) clearance on 2008-06-25, under 510(k) number K080381.

Who is the listed applicant for QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA?

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

What is the FDA product code for QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA?

The FDA product code for QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA is LAF.

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Other records listing Quest Diagnostics, Inc. 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.

K062929QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIAK051161QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)K042726QUEST DIAGNOSTICS HAIRCHECK-DT (PCPK042725QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)K040257QUEST DIAGNOSTICS HAIRCHECK-DT (THC)K023626AML HAIRCHECK-DT (COCAINE)

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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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