Atlas FDA

ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138

FDA 510(k) clearance K100200 · decided 2010-08-02

Clearance details

K-number
K100200
Device name
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2010-01-25
Decision date
2010-08-02
Days to decision
189 days
Clearance type
Traditional
Product code
LDP
Device class
2
Regulation number
862.3030
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative de recall (Z-2416-2015)Siemens Healthcare Diagnostics, Inc.2015-08-19

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