FDA 510(k)

SANDARE CYANMETHEMOGLOBIN STANDARD

K-Number: K792358 · 1979-12-31

Decision Date1979-12-31

Product CodeKRZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

SANDARE CYANMETHEMOGLOBIN STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Sandare Chemical Co., Inc.. It received FDA 510(k) clearance on 1979-12-31 under 510(k) number K792358. 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 SANDARE CYANMETHEMOGLOBIN STANDARD?

SANDARE CYANMETHEMOGLOBIN STANDARD is a medical device that received FDA 510(k) clearance on 1979-12-31. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K792358.

When did SANDARE CYANMETHEMOGLOBIN STANDARD receive FDA 510(k) clearance?

SANDARE CYANMETHEMOGLOBIN STANDARD received FDA 510(k) clearance on 1979-12-31, under 510(k) number K792358.

Who is the listed applicant for SANDARE CYANMETHEMOGLOBIN STANDARD?

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

What is the FDA product code for SANDARE CYANMETHEMOGLOBIN STANDARD?

The FDA product code for SANDARE CYANMETHEMOGLOBIN STANDARD is KRZ.

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Other records listing Sandare Chemical Co., Inc. as applicant

K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST K862556SANDARE GLYCOHEMOGLOBIN PROCEDURE K860684SANDARE BCG ALBUMIN PROCEDURE K851395SANDARE IRON-BINDING CAPACITY PROCEDURE K851394SANDARE IRON PROCEDURE K844498SANDARE ALKALINE PHOSPHATASE PROCEDURE

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Related Devices (Code: KRZ)

K052101C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CRoche Diagnostics K041130CDS 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.