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FDA 510(k)

LIQUI-HEME HEMOGLOBIN CALIBRATORS

K-Number: K842668 · 1985-03-05

ApplicantBiodiagnostic Intl
Decision Date1985-03-05
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LIQUI-HEME HEMOGLOBIN CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Biodiagnostic Intl. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K842668. 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 LIQUI-HEME HEMOGLOBIN CALIBRATORS?

LIQUI-HEME HEMOGLOBIN CALIBRATORS is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is Biodiagnostic Intl. The 510(k) number is K842668.

When did LIQUI-HEME HEMOGLOBIN CALIBRATORS receive FDA 510(k) clearance?

LIQUI-HEME HEMOGLOBIN CALIBRATORS received FDA 510(k) clearance on 1985-03-05, under 510(k) number K842668.

Who is the listed applicant for LIQUI-HEME HEMOGLOBIN CALIBRATORS?

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

What is the FDA product code for LIQUI-HEME HEMOGLOBIN CALIBRATORS?

The FDA product code for LIQUI-HEME HEMOGLOBIN CALIBRATORS is KRZ.

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Other records listing Biodiagnostic Intl 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.

K031296LIQUI-HEME GLYCO A1C ASSAYK881430LIQUI-SERA SERUM ALCOHOL CONTROLSK874459LIQUI-SERA SPINAL FLUID CONTROLK863849LIQUI-SERA COMBO LIGAND/TDM CONTROLSK853906LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)K853887LIQUI-SERA CHEM. MULTIPLE CALIBRATORS

View all 11 devices →

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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