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FDA 510(k)

CARESIDE ALBUMIN

K-Number: K980041 · 1998-02-04

ApplicantExigent Diagnostics, Inc.
Decision Date1998-02-04
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESIDE ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Exigent Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-02-04 under 510(k) number K980041. 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 CARESIDE ALBUMIN?

CARESIDE ALBUMIN is a medical device that received FDA 510(k) clearance on 1998-02-04. The listed applicant is Exigent Diagnostics, Inc.. The 510(k) number is K980041.

When did CARESIDE ALBUMIN receive FDA 510(k) clearance?

CARESIDE ALBUMIN received FDA 510(k) clearance on 1998-02-04, under 510(k) number K980041.

Who is the listed applicant for CARESIDE ALBUMIN?

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

What is the FDA product code for CARESIDE ALBUMIN?

The FDA product code for CARESIDE ALBUMIN is CIX.

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Other records listing Exigent Diagnostics, 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.

K982118CARESIDE ANALYZERK981899CARESIDE HDL-CHOLESTEROLK981183CARESIDE GLUCOSEK980043CARESIDE CREATININEK980056CARESIDE ANALYZERK980057CARESIDE BUN

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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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