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FDA 510(k)

CHEMISTRY, COULTER

K-Number: K770679 · 1977-05-03

ApplicantCoulter Electronics, Inc.
Decision Date1977-05-03
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMISTRY, COULTER 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 1977-05-03 under 510(k) number K770679. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMISTRY, COULTER?

CHEMISTRY, COULTER is a medical device that received FDA 510(k) clearance on 1977-05-03. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K770679.

When did CHEMISTRY, COULTER receive FDA 510(k) clearance?

CHEMISTRY, COULTER received FDA 510(k) clearance on 1977-05-03, under 510(k) number K770679.

Who is the listed applicant for CHEMISTRY, COULTER?

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 CHEMISTRY, COULTER?

The FDA product code for CHEMISTRY, COULTER is JJE.

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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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