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FDA 510(k)

AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE

K-Number: K851923 · 1985-05-24

ApplicantAmresco, Inc.
Decision Date1985-05-24
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1985-05-24 under 510(k) number K851923. 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 AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE?

AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE is a medical device that received FDA 510(k) clearance on 1985-05-24. The listed applicant is Amresco, Inc.. The 510(k) number is K851923.

When did AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE receive FDA 510(k) clearance?

AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE received FDA 510(k) clearance on 1985-05-24, under 510(k) number K851923.

Who is the listed applicant for AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE?

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 SMA PHOSPHATE BUFFER CONCENTRATE?

The FDA product code for AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE 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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