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FDA 510(k)

CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT

K-Number: K822327 · 1982-11-16

ApplicantInterscience, Inc.
Decision Date1982-11-16
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT is the device name listed in this FDA 510(k) record. The listed applicant is Interscience, Inc.. It received FDA 510(k) clearance on 1982-11-16 under 510(k) number K822327. 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 CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT?

CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Interscience, Inc.. The 510(k) number is K822327.

When did CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT receive FDA 510(k) clearance?

CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT received FDA 510(k) clearance on 1982-11-16, under 510(k) number K822327.

Who is the listed applicant for CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT?

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

What is the FDA product code for CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT?

The FDA product code for CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT 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, 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.

K822324RED CELL LYSING REAGENT 78N 1915-1K822325BLOOD CELL DILUENT 78N 1913K822326BLENDED DETERGENT-78N 1912-1

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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