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FDA 510(k)

CELL-DYN 3000 CONTROL

K-Number: K902391 · 1990-08-22

ApplicantUnipath , Ltd.
Decision Date1990-08-22
Product CodeJCN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN 3000 CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1990-08-22 under 510(k) number K902391. The device is classified under product code JCN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELL-DYN 3000 CONTROL?

CELL-DYN 3000 CONTROL is a medical device that received FDA 510(k) clearance on 1990-08-22. The listed applicant is Unipath , Ltd.. The 510(k) number is K902391.

When did CELL-DYN 3000 CONTROL receive FDA 510(k) clearance?

CELL-DYN 3000 CONTROL received FDA 510(k) clearance on 1990-08-22, under 510(k) number K902391.

Who is the listed applicant for CELL-DYN 3000 CONTROL?

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

What is the FDA product code for CELL-DYN 3000 CONTROL?

The FDA product code for CELL-DYN 3000 CONTROL is JCN.

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Related Devices (Code: JCN)

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K993825PARA TECH PLUS RETICSStreck Laboratories, Inc.K942209LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGHBio-RadK934497CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLER&D Systems, Inc.K911582STAK-CHEXStreck Laboratories, Inc.K902389TRI-COUNT 16Hematronix, Inc.K901875PARA 12 PLUSStreck 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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