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FDA 510(k)

COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE

K-Number: K833708 · 1984-01-04

ApplicantWorthington Diagnostic Systems
Decision Date1984-01-04
Product CodeLKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE 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 1984-01-04 under 510(k) number K833708. The device is classified under product code LKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE?

COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE is a medical device that received FDA 510(k) clearance on 1984-01-04. The listed applicant is Worthington Diagnostic Systems. The 510(k) number is K833708.

When did COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE receive FDA 510(k) clearance?

COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE received FDA 510(k) clearance on 1984-01-04, under 510(k) number K833708.

Who is the listed applicant for COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE?

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* M1000 HEMOGLOBIN & ERYTHROCYTE?

The FDA product code for COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE is LKZ.

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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.

K832785COMPUR* EASY TOUCH URIC ACID REAGENTK832749EASYTOUCH BUN REAGENT SETK832427EASYTOUCH TROMBOPLASTIN REAGENTK832748COMPUR* EASYTOUCH TOTAL BILIRUBINK832750EASYTOUCH HEMOGLOBIN REAGENTK832426EASYTOUCH TRIGLYCERIDES REAGENT SET

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Related Devices (Code: LKZ)

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.

K832771ERYTHROCYTE TESTBio-Analytics Laboratories, 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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