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FDA 510(k)

DART IMMUNOGLOBULINS REAGENT SYSTEM

K-Number: K851541 · 1985-07-15

ApplicantCoulter Electronics, Inc.
Decision Date1985-07-15
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DART IMMUNOGLOBULINS REAGENT SYSTEM 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 1985-07-15 under 510(k) number K851541. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DART IMMUNOGLOBULINS REAGENT SYSTEM?

DART IMMUNOGLOBULINS REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1985-07-15. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K851541.

When did DART IMMUNOGLOBULINS REAGENT SYSTEM receive FDA 510(k) clearance?

DART IMMUNOGLOBULINS REAGENT SYSTEM received FDA 510(k) clearance on 1985-07-15, under 510(k) number K851541.

Who is the listed applicant for DART IMMUNOGLOBULINS REAGENT SYSTEM?

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 DART IMMUNOGLOBULINS REAGENT SYSTEM?

The FDA product code for DART IMMUNOGLOBULINS REAGENT SYSTEM is DEW.

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Other records listing Coulter Electronics, Inc. as applicant

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Related Devices (Code: DEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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