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FDA 510(k)

DADE HEMATOLOGY CALIBRATOR PLUS

K-Number: K840010 · 1984-04-19

ApplicantAmerican Dade
Decision Date1984-04-19
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE HEMATOLOGY CALIBRATOR PLUS is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-04-19 under 510(k) number K840010. 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 DADE HEMATOLOGY CALIBRATOR PLUS?

DADE HEMATOLOGY CALIBRATOR PLUS is a medical device that received FDA 510(k) clearance on 1984-04-19. The listed applicant is American Dade. The 510(k) number is K840010.

When did DADE HEMATOLOGY CALIBRATOR PLUS receive FDA 510(k) clearance?

DADE HEMATOLOGY CALIBRATOR PLUS received FDA 510(k) clearance on 1984-04-19, under 510(k) number K840010.

Who is the listed applicant for DADE HEMATOLOGY CALIBRATOR PLUS?

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

What is the FDA product code for DADE HEMATOLOGY CALIBRATOR PLUS?

The FDA product code for DADE HEMATOLOGY CALIBRATOR PLUS is KRZ.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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