FDA 510(k)

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P

K-Number: K060325 · 2006-08-16

Decision Date2006-08-16

Product CodeCIG

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Abx. It received FDA 510(k) clearance on 2006-08-16 under 510(k) number K060325. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P?

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P is a medical device that received FDA 510(k) clearance on 2006-08-16. The listed applicant is Horiba Abx. The 510(k) number is K060325.

When did ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P receive FDA 510(k) clearance?

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P received FDA 510(k) clearance on 2006-08-16, under 510(k) number K060325.

Who is the listed applicant for ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P?

The FDA 510(k) record lists Horiba Abx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P?

The FDA product code for ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P is CIG.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.