Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES

K-Number: K042927 · 2005-04-15

ApplicantGreiner Bio-One Vacuette North America
Decision Date2005-04-15
Product CodePJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One Vacuette North America. It received FDA 510(k) clearance on 2005-04-15 under 510(k) number K042927. The device is classified under product code PJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES?

VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES is a medical device that received FDA 510(k) clearance on 2005-04-15. The listed applicant is Greiner Bio-One Vacuette North America. The 510(k) number is K042927.

When did VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES receive FDA 510(k) clearance?

VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES received FDA 510(k) clearance on 2005-04-15, under 510(k) number K042927.

Who is the listed applicant for VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES?

The FDA 510(k) record lists Greiner Bio-One Vacuette North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES?

The FDA product code for VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES is PJE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Greiner Bio-One Vacuette North America 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.

K080235SAFETY INFUSION SETK033478VACUETTE QUICKSHIELD SAFETY TUBE HOLDERK023971VACUETTE TRACE ELEMENTS TUBESK011699VACUETTE EVACUATED BLOOD COLLECTION TUBES

Related Devices (Code: PJE)

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.

K231469PAXgene® Blood DNA TubePreanalytix GmbHK031359S-MONOVETTE EDTA K2-GELSarstedt, Inc.K014104VACUETTE EDTA K2 TUBESGreiner Vacuette North America, Inc.K012043VACUETTE EDTA K2 GEL TUBESGreiner Vacuette North America, Inc.K010328MULTIPLE (IZON DNA BLOOD COLLECTION KIT)Izon Business Products, Inc.K972075VACUTAINER BRAND PPT PLASMA PREPARATION TUBEBecton Dickinson Vacutainer Systems

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.

↑