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FDA 510(k)

VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)

K-Number: K972404 · 1997-07-22

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1997-07-22
Product CodeKJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) 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 1997-07-22 under 510(k) number K972404. The device is classified under product code KJA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)?

VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) is a medical device that received FDA 510(k) clearance on 1997-07-22. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K972404.

When did VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) receive FDA 510(k) clearance?

VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) received FDA 510(k) clearance on 1997-07-22, under 510(k) number K972404.

Who is the listed applicant for VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)?

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 VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)?

The FDA product code for VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) is KJA.

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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: KJA)

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.

K933228KAPTON PEEL POUCHAmerican Fluoroseal Corp.K885121CELL SCRAPERBd Becton Dickinson Vacutainer Systems PreanalyticK873889TISSUE CULTURE TUBESNunc, Inc.K873890TISSUE CULTURE FLASKSNunc, Inc.K871324DU PONT STERICELL CELL CULTURE SYSTEME.I. Dupont DE Nemours & Co., Inc.K870865TISSUE CULTURE BAGAmerican Fluoroseal Corp.

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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