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FDA 510(k)

ANTITHROMBIN III RIA

K-Number: K780012 · 1978-01-20

ApplicantRia Diagnostics
Decision Date1978-01-20
Product CodeDDQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ANTITHROMBIN III RIA is the device name listed in this FDA 510(k) record. The listed applicant is Ria Diagnostics. It received FDA 510(k) clearance on 1978-01-20 under 510(k) number K780012. The device is classified under product code DDQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTITHROMBIN III RIA?

ANTITHROMBIN III RIA is a medical device that received FDA 510(k) clearance on 1978-01-20. The listed applicant is Ria Diagnostics. The 510(k) number is K780012.

When did ANTITHROMBIN III RIA receive FDA 510(k) clearance?

ANTITHROMBIN III RIA received FDA 510(k) clearance on 1978-01-20, under 510(k) number K780012.

Who is the listed applicant for ANTITHROMBIN III RIA?

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

What is the FDA product code for ANTITHROMBIN III RIA?

The FDA product code for ANTITHROMBIN III RIA is DDQ.

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Other records listing Ria Diagnostics as applicant

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.

K855033T-3 UPTAKE/RIASSAYK854798T-4 RIASSAYK852537T-3 RIASSAYK810296DIGOXIN RIA ASSAYK801691TSH RIASSAYK792062THEOPHYLLINE RIASSAY

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Related Devices (Code: DDQ)

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.

K972257N-ASSAY TIA ANTITHROMBIN III TEST KITCrestat Diagnostics, Inc.K935307DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISABaxter Diagnostics, Inc.K932713TRACE TRANSFERRIN REAGENTTrace Scientific , Ltd.

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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