Atlas FDA

PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT

FDA 510(k) clearance K103788 · decided 2011-11-08

Clearance details

K-number
K103788
Device name
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
Applicant
HORIBA ABX SAS
Decision
Substantially Equivalent
Date received
2010-12-27
Decision date
2011-11-08
Days to decision
316 days
Clearance type
Traditional
Product code
CFR
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Montpellier, FR
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry recall (Z-0633-2013)Horiba Instruments, Inc dba Horiba Medical2013-01-03