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FDA 510(k)

HEMATOLOGY CALIBRATOR CONTROL

K-Number: K854166 · 1986-03-12

ApplicantInterscience Diagnostics, Inc.
Decision Date1986-03-12
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY CALIBRATOR CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Interscience Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-03-12 under 510(k) number K854166. 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 HEMATOLOGY CALIBRATOR CONTROL?

HEMATOLOGY CALIBRATOR CONTROL is a medical device that received FDA 510(k) clearance on 1986-03-12. The listed applicant is Interscience Diagnostics, Inc.. The 510(k) number is K854166.

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

HEMATOLOGY CALIBRATOR CONTROL received FDA 510(k) clearance on 1986-03-12, under 510(k) number K854166.

Who is the listed applicant for HEMATOLOGY CALIBRATOR CONTROL?

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

What is the FDA product code for HEMATOLOGY CALIBRATOR CONTROL?

The FDA product code for HEMATOLOGY CALIBRATOR CONTROL 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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Other records listing Interscience 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.

K842070IDD DETERGENTK842069IDL-LYSING REAGENTK842068IDI ISOTONIC DILUENT

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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