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FDA 510(k)

COMPUR* M1100 HEMATRCRIT SYSTEM

K-Number: K831318 · 1983-06-08

ApplicantWorthington Diagnostic Systems
Decision Date1983-06-08
Product CodeJPI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COMPUR* M1100 HEMATRCRIT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Diagnostic Systems. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831318. The device is classified under product code JPI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUR* M1100 HEMATRCRIT SYSTEM?

COMPUR* M1100 HEMATRCRIT SYSTEM is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Worthington Diagnostic Systems. The 510(k) number is K831318.

When did COMPUR* M1100 HEMATRCRIT SYSTEM receive FDA 510(k) clearance?

COMPUR* M1100 HEMATRCRIT SYSTEM received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831318.

Who is the listed applicant for COMPUR* M1100 HEMATRCRIT SYSTEM?

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

What is the FDA product code for COMPUR* M1100 HEMATRCRIT SYSTEM?

The FDA product code for COMPUR* M1100 HEMATRCRIT SYSTEM is JPI.

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Other records listing Worthington Diagnostic Systems 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.

K833708COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTEK832749EASYTOUCH BUN REAGENT SETK832427EASYTOUCH TROMBOPLASTIN REAGENTK832748COMPUR* EASYTOUCH TOTAL BILIRUBINK832785COMPUR* EASY TOUCH URIC ACID REAGENTK832750EASYTOUCH HEMOGLOBIN REAGENT

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Related Devices (Code: JPI)

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K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K163342i-STAT Hematocrit test with i-STAT Alinity SystemAbbott LaboratoriesK950942CRIT-LINE HEMATOCRIT ALERTIn-Line Diagnostics Corp.K924167CRIT-LINENoninvasive Medical Technology Corp.K903698STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBESStatspin TechnologiesK902028STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READERNorfolk Scientific, 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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