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FDA 510(k)

CALIBRATION STANDARD-HEMOGLOBIN

K-Number: K831814 · 1983-07-28

ApplicantUnited Diagnostics, Inc.
Decision Date1983-07-28
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CALIBRATION STANDARD-HEMOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is United Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-07-28 under 510(k) number K831814. 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 CALIBRATION STANDARD-HEMOGLOBIN?

CALIBRATION STANDARD-HEMOGLOBIN is a medical device that received FDA 510(k) clearance on 1983-07-28. The listed applicant is United Diagnostics, Inc.. The 510(k) number is K831814.

When did CALIBRATION STANDARD-HEMOGLOBIN receive FDA 510(k) clearance?

CALIBRATION STANDARD-HEMOGLOBIN received FDA 510(k) clearance on 1983-07-28, under 510(k) number K831814.

Who is the listed applicant for CALIBRATION STANDARD-HEMOGLOBIN?

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

What is the FDA product code for CALIBRATION STANDARD-HEMOGLOBIN?

The FDA product code for CALIBRATION STANDARD-HEMOGLOBIN is KRZ.

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Other records listing United Diagnostics, 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.

K884977GAS TRAK PLUSK862278GAS-TRAKK843986STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3K844018GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3K831389STAT-TRAK LIQUID ELECTROLYTE CONTROLK831813CO-OXIMETER CONTROL

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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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