FDA 510(k)

ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP

K-Number: K062180 · 2006-10-02

Decision Date2006-10-02

Product CodeJFJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP is the device name listed in this FDA 510(k) record. The listed applicant is Horiba Abx. It received FDA 510(k) clearance on 2006-10-02 under 510(k) number K062180. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP?

ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP is a medical device that received FDA 510(k) clearance on 2006-10-02. The listed applicant is Horiba Abx. The 510(k) number is K062180.

When did ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP receive FDA 510(k) clearance?

ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP received FDA 510(k) clearance on 2006-10-02, under 510(k) number K062180.

Who is the listed applicant for ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP?

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 AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP?

The FDA product code for ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP is JFJ.

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Other records listing Horiba Abx as applicant

K073309ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT K081276ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H K071779ABX PENTRA URINE CAL K072115ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H K070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP K062737CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

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Related Devices (Code: JFJ)

K210633Amylase2Abbott Ireland Diagnostics Division K191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALBiosystems S.A.K130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYHitachi Chemical Diagnostics, Inc.K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroup K091846SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607Beckman Coulter, Inc.

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.