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FDA 510(k)

H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS

K-Number: K864664 · 1987-02-06

ApplicantTechnicon Instruments Corp.
Decision Date1987-02-06
Product CodeKSA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1987-02-06 under 510(k) number K864664. 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 H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS?

H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS is a medical device that received FDA 510(k) clearance on 1987-02-06. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K864664.

When did H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS receive FDA 510(k) clearance?

H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS received FDA 510(k) clearance on 1987-02-06, under 510(k) number K864664.

Who is the listed applicant for H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS?

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

What is the FDA product code for H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS?

The FDA product code for H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS is KSA.

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Other records listing Technicon Instruments Corp. as applicant

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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.K897060CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLER&D Systems, Inc.K881161TECH-CAL(TM)/MULTIPLER&D Systems, Inc.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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