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FDA 510(k)

HGB-CAL SET/MULTIPLE

K-Number: K893984 · 1989-08-15

ApplicantR&D Systems, Inc.
Decision Date1989-08-15
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HGB-CAL SET/MULTIPLE is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K893984. 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 HGB-CAL SET/MULTIPLE?

HGB-CAL SET/MULTIPLE is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is R&D Systems, Inc.. The 510(k) number is K893984.

When did HGB-CAL SET/MULTIPLE receive FDA 510(k) clearance?

HGB-CAL SET/MULTIPLE received FDA 510(k) clearance on 1989-08-15, under 510(k) number K893984.

Who is the listed applicant for HGB-CAL SET/MULTIPLE?

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

What is the FDA product code for HGB-CAL SET/MULTIPLE?

The FDA product code for HGB-CAL SET/MULTIPLE is KRZ.

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Other records listing R&D Systems, Inc. as applicant

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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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