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FDA 510(k)

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE

K-Number: K897060 · 1990-01-02

ApplicantR&D Systems, Inc.
Decision Date1990-01-02
Product CodeKSA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/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 1990-01-02 under 510(k) number K897060. The device is classified under product code KSA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE?

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE is a medical device that received FDA 510(k) clearance on 1990-01-02. The listed applicant is R&D Systems, Inc.. The 510(k) number is K897060.

When did CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE receive FDA 510(k) clearance?

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE received FDA 510(k) clearance on 1990-01-02, under 510(k) number K897060.

Who is the listed applicant for CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/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 CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE?

The FDA product code for CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE is KSA.

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Other records listing R&D Systems, 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.

K160606BC-5D Hematology ControlK130962R&D 5D RETIC HEMATOLOGY CONTROLK101578R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROLK100050R & D SYSTEMS XERET HEMATOLOGY CONTROLK091433R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROLK073178HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

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Related Devices (Code: KSA)

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.

K943268SCS-1000 (SYSMEX CALIBRATOR SYSTEM)Streck Laboratories, Inc.K881161TECH-CAL(TM)/MULTIPLER&D Systems, Inc.K864664H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORSTechnicon Instruments Corp.K854823CBC-CAL/MULTIPLER&D Systems, Inc.K844708TRI-COUNT CALIBRATORHematology Marketing Assoc.K813530HEMOTOLOGY CALIBRATORAmerican Dade

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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