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FDA 510(k)

HEMOCUE HEMOGLOBIN CALIBRATOR

K-Number: K882600 · 1988-07-18

ApplicantReact and Co.
Decision Date1988-07-18
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCUE HEMOGLOBIN CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is React and Co.. It received FDA 510(k) clearance on 1988-07-18 under 510(k) number K882600. The device is classified under product code KRZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCUE HEMOGLOBIN CALIBRATOR?

HEMOCUE HEMOGLOBIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1988-07-18. The listed applicant is React and Co.. The 510(k) number is K882600.

When did HEMOCUE HEMOGLOBIN CALIBRATOR receive FDA 510(k) clearance?

HEMOCUE HEMOGLOBIN CALIBRATOR received FDA 510(k) clearance on 1988-07-18, under 510(k) number K882600.

Who is the listed applicant for HEMOCUE HEMOGLOBIN CALIBRATOR?

The FDA 510(k) record lists React and Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOCUE HEMOGLOBIN CALIBRATOR?

The FDA product code for HEMOCUE HEMOGLOBIN CALIBRATOR is KRZ.

Related Clinical Trials

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.

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Related Devices (Code: KRZ)

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.

K052101C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CRoche DiagnosticsK041130CDS HEMATOLOGY CALIBRATOR (CDS CAL)Clinical Diagnostic Solutions, Inc.K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSAlko Diagnostic Corp.K951071ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERSAlko Diagnostic Corp.K902892CELL-DYN CALIBRATORUnipath , Ltd.K896921RAICHEM TM HEMOGLOBIN CALIBRATORReagents Applications, 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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