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FDA 510(k)

CONTROL DIAGNOSTICS PLATELET CONTROL

K-Number: K821851 · 1982-09-02

ApplicantImmunogenetics
Decision Date1982-09-02
Product CodeKRY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CONTROL DIAGNOSTICS PLATELET CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Immunogenetics. It received FDA 510(k) clearance on 1982-09-02 under 510(k) number K821851. The device is classified under product code KRY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTROL DIAGNOSTICS PLATELET CONTROL?

CONTROL DIAGNOSTICS PLATELET CONTROL is a medical device that received FDA 510(k) clearance on 1982-09-02. The listed applicant is Immunogenetics. The 510(k) number is K821851.

When did CONTROL DIAGNOSTICS PLATELET CONTROL receive FDA 510(k) clearance?

CONTROL DIAGNOSTICS PLATELET CONTROL received FDA 510(k) clearance on 1982-09-02, under 510(k) number K821851.

Who is the listed applicant for CONTROL DIAGNOSTICS PLATELET CONTROL?

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

What is the FDA product code for CONTROL DIAGNOSTICS PLATELET CONTROL?

The FDA product code for CONTROL DIAGNOSTICS PLATELET CONTROL is KRY.

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Related Devices (Code: KRY)

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.

K862122S-CAL HEMATOLOGY CALIBRATORCoulter Electronics, Inc.K852016LASER PLATELETCAL/MULTIPLER&D Systems, Inc.K843910COULTER MEAN PLATELET VOLUME CALIBRATORCoulter Electronics, Inc.K840794S-CAL HEMATOLOGY CALIBRATORCoulter Electronics, Inc.K781601TEKNI-CALStreck Laboratories, Inc.K781133PC-CALIBRATORStreck Laboratories, 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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