Atlas FDA

ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33

FDA 510(k) clearance K081231 · decided 2008-09-26

Clearance details

K-number
K081231
Device name
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2008-05-01
Decision date
2008-09-26
Days to decision
148 days
Clearance type
Traditional
Product code
DLZ
Device class
2
Regulation number
862.3660
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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