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ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL

FDA 510(k) clearance K060434 · decided 2007-06-05

Clearance details

K-number
K060434
Device name
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
Applicant
Horiba Abx
Decision
Substantially Equivalent
Date received
2006-02-21
Decision date
2007-06-05
Days to decision
469 days
Clearance type
Traditional
Product code
CIX
Device class
2
Regulation number
862.1035
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

No recalls on record reference this clearance.