FDA 510(k)

IGOXIN SOLID PHASE RIA

K-Number: K771638 · 1977-10-07

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1977-10-07

Product CodeDPO

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

IGOXIN SOLID PHASE RIA is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1977-10-07 under 510(k) number K771638. The device is classified under product code DPO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGOXIN SOLID PHASE RIA?

IGOXIN SOLID PHASE RIA is a medical device that received FDA 510(k) clearance on 1977-10-07. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K771638.

When did IGOXIN SOLID PHASE RIA receive FDA 510(k) clearance?

IGOXIN SOLID PHASE RIA received FDA 510(k) clearance on 1977-10-07, under 510(k) number K771638.

Who is the listed applicant for IGOXIN SOLID PHASE RIA?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IGOXIN SOLID PHASE RIA?

The FDA product code for IGOXIN SOLID PHASE RIA is DPO.

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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.