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FDA 510(k)

COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY

K-Number: K851942 · 1985-05-31

ApplicantCoulter Electronics, Inc.
Decision Date1985-05-31
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY 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 1985-05-31 under 510(k) number K851942. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY?

COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY is a medical device that received FDA 510(k) clearance on 1985-05-31. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K851942.

When did COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY receive FDA 510(k) clearance?

COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY received FDA 510(k) clearance on 1985-05-31, under 510(k) number K851942.

Who is the listed applicant for COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY?

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 DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY?

The FDA product code for COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY is JJY.

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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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