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FDA 510(k)

AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT

K-Number: K860663 · 1986-04-11

ApplicantAmresco, Inc.
Decision Date1986-04-11
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1986-04-11 under 510(k) number K860663. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT?

AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is Amresco, Inc.. The 510(k) number is K860663.

When did AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT receive FDA 510(k) clearance?

AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT received FDA 510(k) clearance on 1986-04-11, under 510(k) number K860663.

Who is the listed applicant for AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT?

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

What is the FDA product code for AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT?

The FDA product code for AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT is JHY.

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Other records listing Amresco, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K905618GGT REAGENTK904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176K905684ALKALINE PHOSPHATASEK905544MAGNESIUM REAGENTK905284HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173K904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116

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Related Devices (Code: JHY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132571ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche DiagnosticsK070835OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (IrishK022757SPIFE CK KIT, MODEL 3332, 3333Helena LaboratoriesK022654MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MBRoche Diagnostics Corp.K974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, 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.

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