Atlas FDA

QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA

FDA 510(k) clearance K080381 · decided 2008-06-25

Clearance details

K-number
K080381
Device name
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
Applicant
Quest Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2008-02-13
Decision date
2008-06-25
Days to decision
133 days
Clearance type
Traditional
Product code
LAF
Device class
2
Regulation number
862.3610
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Lenexa, KS, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.