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FDA 510(k)

MINI-KEM

K-Number: K781576 · 1978-10-03

ApplicantCoulter Electronics, Inc.
Decision Date1978-10-03
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MINI-KEM 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 1978-10-03 under 510(k) number K781576. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI-KEM?

MINI-KEM is a medical device that received FDA 510(k) clearance on 1978-10-03. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K781576.

When did MINI-KEM receive FDA 510(k) clearance?

MINI-KEM received FDA 510(k) clearance on 1978-10-03, under 510(k) number K781576.

Who is the listed applicant for MINI-KEM?

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 MINI-KEM?

The FDA product code for MINI-KEM is JJQ.

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.

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