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FDA 510(k)

EASY ST ANALYZER SYSTEM

K-Number: K872813 · 1987-08-13

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-08-13
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY ST ANALYZER SYSTEM 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 1987-08-13 under 510(k) number K872813. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY ST ANALYZER SYSTEM?

EASY ST ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1987-08-13. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K872813.

When did EASY ST ANALYZER SYSTEM receive FDA 510(k) clearance?

EASY ST ANALYZER SYSTEM received FDA 510(k) clearance on 1987-08-13, under 510(k) number K872813.

Who is the listed applicant for EASY ST ANALYZER SYSTEM?

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 EASY ST ANALYZER SYSTEM?

The FDA product code for EASY ST ANALYZER SYSTEM is JJE.

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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: JJE)

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.

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK110035INDIKOThermofisher Scientific OYK073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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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