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FDA 510(k)

ICROTAINEO BRAND TUBE

K-Number: K771370 · 1977-08-03

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1977-08-03
Product CodeGJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ICROTAINEO BRAND TUBE 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 1977-08-03 under 510(k) number K771370. The device is classified under product code GJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICROTAINEO BRAND TUBE?

ICROTAINEO BRAND TUBE is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K771370.

When did ICROTAINEO BRAND TUBE receive FDA 510(k) clearance?

ICROTAINEO BRAND TUBE received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771370.

Who is the listed applicant for ICROTAINEO BRAND TUBE?

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 ICROTAINEO BRAND TUBE?

The FDA product code for ICROTAINEO BRAND TUBE is GJE.

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Related Devices (Code: GJE)

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.

K962596CUSTOMED BLOOD EXTRACTION KITCustomed, Inc.K925468JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KITJ.J. Skinner, Inc.K780303AUTO ISO-FILTER COLLECTION TUBE CAPBd Becton Dickinson Vacutainer Systems PreanalyticK771489RTERIAL BLOOD SAMPLING KITBd Becton Dickinson Vacutainer Systems PreanalyticK761177SODIUM CITRATEBio/Data Corp.K760086TRAY, BLOOD SAMPLING (PULSATOR II)Concord Laboratories, Inc.

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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