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FDA 510(k)

FLOW-PAC SGPT REAGENT

K-Number: K830959 · 1983-05-04

ApplicantAmresco, Inc.
Decision Date1983-05-04
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLOW-PAC SGPT 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 1983-05-04 under 510(k) number K830959. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOW-PAC SGPT REAGENT?

FLOW-PAC SGPT REAGENT is a medical device that received FDA 510(k) clearance on 1983-05-04. The listed applicant is Amresco, Inc.. The 510(k) number is K830959.

When did FLOW-PAC SGPT REAGENT receive FDA 510(k) clearance?

FLOW-PAC SGPT REAGENT received FDA 510(k) clearance on 1983-05-04, under 510(k) number K830959.

Who is the listed applicant for FLOW-PAC SGPT 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 FLOW-PAC SGPT REAGENT?

The FDA product code for FLOW-PAC SGPT REAGENT is CKA.

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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: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, 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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