FDA 510(k)

IMMUNO-SURE

K-Number: K864611 · 1987-02-04

Decision Date1987-02-04

Product Code

DecisionSubstantially Equivalent

Device Summary

IMMUNO-SURE 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 1987-02-04 under 510(k) number K864611. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNO-SURE?

IMMUNO-SURE is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K864611.

When did IMMUNO-SURE receive FDA 510(k) clearance?

IMMUNO-SURE received FDA 510(k) clearance on 1987-02-04, under 510(k) number K864611.

Who is the listed applicant for IMMUNO-SURE?

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

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Other records listing Coulter Electronics, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.