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FDA 510(k)

SERATEST RF LATEX DETERMINATION

K-Number: K840863 · 1984-04-04

ApplicantSeragen Diagnostics, Inc.
Decision Date1984-04-04
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERATEST RF LATEX DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K840863. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERATEST RF LATEX DETERMINATION?

SERATEST RF LATEX DETERMINATION is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K840863.

When did SERATEST RF LATEX DETERMINATION receive FDA 510(k) clearance?

SERATEST RF LATEX DETERMINATION received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840863.

Who is the listed applicant for SERATEST RF LATEX DETERMINATION?

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

What is the FDA product code for SERATEST RF LATEX DETERMINATION?

The FDA product code for SERATEST RF LATEX DETERMINATION is DHR.

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Related Devices (Code: DHR)

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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