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FDA 510(k)

LEUKOCYTE VOL. ANALYSIS APPARATUS

K-Number: K802208 · 1980-09-17

ApplicantCoulter Electronics, Inc.
Decision Date1980-09-17
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LEUKOCYTE VOL. ANALYSIS APPARATUS 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 1980-09-17 under 510(k) number K802208. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEUKOCYTE VOL. ANALYSIS APPARATUS?

LEUKOCYTE VOL. ANALYSIS APPARATUS is a medical device that received FDA 510(k) clearance on 1980-09-17. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K802208.

When did LEUKOCYTE VOL. ANALYSIS APPARATUS receive FDA 510(k) clearance?

LEUKOCYTE VOL. ANALYSIS APPARATUS received FDA 510(k) clearance on 1980-09-17, under 510(k) number K802208.

Who is the listed applicant for LEUKOCYTE VOL. ANALYSIS APPARATUS?

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 LEUKOCYTE VOL. ANALYSIS APPARATUS?

The FDA product code for LEUKOCYTE VOL. ANALYSIS APPARATUS is GKL.

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Other records listing Coulter Electronics, Inc. as applicant

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Related Devices (Code: GKL)

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.

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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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