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FDA 510(k)

C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C

K-Number: K052101 · 2005-08-26

ApplicantRoche Diagnostics
Decision Date2005-08-26
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2005-08-26 under 510(k) number K052101. 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 C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C?

C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C is a medical device that received FDA 510(k) clearance on 2005-08-26. The listed applicant is Roche Diagnostics. The 510(k) number is K052101.

When did C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C receive FDA 510(k) clearance?

C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C received FDA 510(k) clearance on 2005-08-26, under 510(k) number K052101.

Who is the listed applicant for C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C?

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

What is the FDA product code for C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C?

The FDA product code for C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C is KRZ.

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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.

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.K893984HGB-CAL SET/MULTIPLER&D Systems, 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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