Atlas FDA

HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k) clearance K060318 · decided 2006-08-08

Clearance details

K-number
K060318
Device name
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
Applicant
Horiba Abx
Decision
Substantially Equivalent
Date received
2006-02-08
Decision date
2006-08-08
Days to decision
181 days
Clearance type
Traditional
Product code
CIT
Device class
2
Regulation number
862.1100
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Montpellier, FR
Third-party review
No
Expedited review
No

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RecordFirmDate
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Recalls involving this device

RecordFirmDate
ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic r recall (Z-0632-2013)Horiba Instruments, Inc dba Horiba Medical2013-01-03