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FDA 510(k)

RTERIAL BLOOD SAMPLING KIT

K-Number: K771489 · 1977-08-22

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1977-08-22
Product CodeGJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RTERIAL BLOOD SAMPLING KIT 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 1977-08-22 under 510(k) number K771489. 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 RTERIAL BLOOD SAMPLING KIT?

RTERIAL BLOOD SAMPLING KIT is a medical device that received FDA 510(k) clearance on 1977-08-22. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K771489.

When did RTERIAL BLOOD SAMPLING KIT receive FDA 510(k) clearance?

RTERIAL BLOOD SAMPLING KIT received FDA 510(k) clearance on 1977-08-22, under 510(k) number K771489.

Who is the listed applicant for RTERIAL BLOOD SAMPLING KIT?

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 RTERIAL BLOOD SAMPLING KIT?

The FDA product code for RTERIAL BLOOD SAMPLING KIT is GJE.

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Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic 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.

K003062BACTEC MGIT 960 SIR KITSK0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGEK003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLEK002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16K001364BD DIRECTIGEN FLU A+BK000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

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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 PreanalyticK771370ICROTAINEO BRAND TUBEBd 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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