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FDA 510(k)

SYSTEMATE ALBUMIN

K-Number: K843108 · 1984-08-27

ApplicantEm Diagnostic Systems, Inc.
Decision Date1984-08-27
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE ALBUMIN is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K843108. 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 SYSTEMATE ALBUMIN?

SYSTEMATE ALBUMIN is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K843108.

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

SYSTEMATE ALBUMIN received FDA 510(k) clearance on 1984-08-27, under 510(k) number K843108.

Who is the listed applicant for SYSTEMATE ALBUMIN?

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

What is the FDA product code for SYSTEMATE ALBUMIN?

The FDA product code for SYSTEMATE ALBUMIN is CIX.

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Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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