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FDA 510(k)

FLOW-PAC ALKALINE PHOSPHATE REAGENT SET

K-Number: K830535 · 1983-03-24

ApplicantAmresco, Inc.
Decision Date1983-03-24
Product CodeCJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLOW-PAC ALKALINE PHOSPHATE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830535. The device is classified under product code CJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOW-PAC ALKALINE PHOSPHATE REAGENT SET?

FLOW-PAC ALKALINE PHOSPHATE REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Amresco, Inc.. The 510(k) number is K830535.

When did FLOW-PAC ALKALINE PHOSPHATE REAGENT SET receive FDA 510(k) clearance?

FLOW-PAC ALKALINE PHOSPHATE REAGENT SET received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830535.

Who is the listed applicant for FLOW-PAC ALKALINE PHOSPHATE REAGENT SET?

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 FLOW-PAC ALKALINE PHOSPHATE REAGENT SET?

The FDA product code for FLOW-PAC ALKALINE PHOSPHATE REAGENT SET is CJF.

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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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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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