FDA 510(k)

COULTER COUNTER MODEL T-660

K-Number: K854114 · 1985-11-05

Decision Date1985-11-05

Product CodeGKL

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

COULTER COUNTER MODEL T-660 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 1985-11-05 under 510(k) number K854114. 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 COULTER COUNTER MODEL T-660?

COULTER COUNTER MODEL T-660 is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K854114.

When did COULTER COUNTER MODEL T-660 receive FDA 510(k) clearance?

COULTER COUNTER MODEL T-660 received FDA 510(k) clearance on 1985-11-05, under 510(k) number K854114.

Who is the listed applicant for COULTER COUNTER MODEL T-660?

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 COULTER COUNTER MODEL T-660?

The FDA product code for COULTER COUNTER MODEL T-660 is GKL.

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Other records listing Coulter Electronics, Inc. as applicant

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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.