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FDA 510(k)

A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM

K-Number: K882587 · 1988-08-08

ApplicantA-Kem, Inc.
Decision Date1988-08-08
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is A-Kem, Inc.. It received FDA 510(k) clearance on 1988-08-08 under 510(k) number K882587. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM?

A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM is a medical device that received FDA 510(k) clearance on 1988-08-08. The listed applicant is A-Kem, Inc.. The 510(k) number is K882587.

When did A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM receive FDA 510(k) clearance?

A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM received FDA 510(k) clearance on 1988-08-08, under 510(k) number K882587.

Who is the listed applicant for A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM?

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

What is the FDA product code for A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM?

The FDA product code for A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM is CIX.

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Other records listing A-Kem, 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.

K884224TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMSK884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSK884225TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMSK884227CALIBRATOR STANDARD KIT FOR ASTRA SYSTEMK882586A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEMK873132BUN REAGENT KIT

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Related Devices (Code: CIX)

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.

K251157Core MetabolicTruvian HealthK203248Albumin BCG2Abbott Ireland Diagnostics DivisionK200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct BilirubinMedicon Hellas S.AK191316VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc.K170901ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400Biosystems S.A.K131488ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENTAlfa Wassermann Diagnostics Technologies, LLC

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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