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FDA 510(k)

RAICHEM TM HEMOGLOBIN CALIBRATOR

K-Number: K896921 · 1990-01-25

ApplicantReagents Applications, Inc.
Decision Date1990-01-25
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RAICHEM TM HEMOGLOBIN CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1990-01-25 under 510(k) number K896921. 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 RAICHEM TM HEMOGLOBIN CALIBRATOR?

RAICHEM TM HEMOGLOBIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1990-01-25. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K896921.

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

RAICHEM TM HEMOGLOBIN CALIBRATOR received FDA 510(k) clearance on 1990-01-25, under 510(k) number K896921.

Who is the listed applicant for RAICHEM TM HEMOGLOBIN CALIBRATOR?

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

What is the FDA product code for RAICHEM TM HEMOGLOBIN CALIBRATOR?

The FDA product code for RAICHEM TM HEMOGLOBIN CALIBRATOR is KRZ.

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Other records listing Reagents Applications, 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.

K982056RAICHEM CO2 REAGENTK972853CHOLESTEROL RAPID LIQUID REAGENTK922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND IIK915191RAI-TROL ELEVATED LIPIDS CONTROLK913398RAICHEM(TM) CREATINE KINASE-MB REAGENTK911900RAICHEM SPIA C3 REAGENT

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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.K893984HGB-CAL SET/MULTIPLER&D Systems, 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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