FDA 510(k)

AMYLASE EPS REAGENT

K-Number: K070064 · 2007-05-22

Decision Date2007-05-22

Product CodeJFJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AMYLASE EPS REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific. It received FDA 510(k) clearance on 2007-05-22 under 510(k) number K070064. 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 AMYLASE EPS REAGENT?

AMYLASE EPS REAGENT is a medical device that received FDA 510(k) clearance on 2007-05-22. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K070064.

When did AMYLASE EPS REAGENT receive FDA 510(k) clearance?

AMYLASE EPS REAGENT received FDA 510(k) clearance on 2007-05-22, under 510(k) number K070064.

Who is the listed applicant for AMYLASE EPS REAGENT?

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

What is the FDA product code for AMYLASE EPS REAGENT?

The FDA product code for AMYLASE EPS REAGENT is JFJ.

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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

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