Atlas FDA

ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H

FDA 510(k) clearance K081276 · decided 2008-09-12

Clearance details

K-number
K081276
Device name
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
Applicant
Horiba Abx
Decision
Substantially Equivalent
Date received
2008-05-05
Decision date
2008-09-12
Days to decision
130 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
ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitativ recall (Z-0743-2016)Horiba Instruments Inc2016-02-02