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FDA 510(k)

SERALYZER HEMOGLOBIN CALIBRATORS

K-Number: K822046 · 1982-07-30

ApplicantMiles Laboratories, Inc.
Decision Date1982-07-30
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SERALYZER HEMOGLOBIN CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K822046. 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 SERALYZER HEMOGLOBIN CALIBRATORS?

SERALYZER HEMOGLOBIN CALIBRATORS is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K822046.

When did SERALYZER HEMOGLOBIN CALIBRATORS receive FDA 510(k) clearance?

SERALYZER HEMOGLOBIN CALIBRATORS received FDA 510(k) clearance on 1982-07-30, under 510(k) number K822046.

Who is the listed applicant for SERALYZER HEMOGLOBIN CALIBRATORS?

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

What is the FDA product code for SERALYZER HEMOGLOBIN CALIBRATORS?

The FDA product code for SERALYZER HEMOGLOBIN CALIBRATORS is KRZ.

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Other records listing Miles Laboratories, 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.

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

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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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