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FDA 510(k)

HEMATOLOGY REFERENCE CONTROL

K-Number: K771753 · 1977-11-28

ApplicantCoulter Electronics, Inc.
Decision Date1977-11-28
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY REFERENCE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K771753. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMATOLOGY REFERENCE CONTROL?

HEMATOLOGY REFERENCE CONTROL is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K771753.

When did HEMATOLOGY REFERENCE CONTROL receive FDA 510(k) clearance?

HEMATOLOGY REFERENCE CONTROL received FDA 510(k) clearance on 1977-11-28, under 510(k) number K771753.

Who is the listed applicant for HEMATOLOGY REFERENCE CONTROL?

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

What is the FDA product code for HEMATOLOGY REFERENCE CONTROL?

The FDA product code for HEMATOLOGY REFERENCE CONTROL is JPK.

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Other records listing Coulter Electronics, Inc. as applicant

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Related Devices (Code: JPK)

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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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