FDA 510(k)

RUBELLA LATEX CARD TEST

K-Number: K811637 · 1981-08-13

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1981-08-13

Product CodeDOK

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

RUBELLA LATEX CARD TEST 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 1981-08-13 under 510(k) number K811637. The device is classified under product code DOK. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBELLA LATEX CARD TEST?

RUBELLA LATEX CARD TEST is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K811637.

When did RUBELLA LATEX CARD TEST receive FDA 510(k) clearance?

RUBELLA LATEX CARD TEST received FDA 510(k) clearance on 1981-08-13, under 510(k) number K811637.

Who is the listed applicant for RUBELLA LATEX CARD TEST?

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 RUBELLA LATEX CARD TEST?

The FDA product code for RUBELLA LATEX CARD TEST is DOK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.