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FDA 510(k)

VACUETTE EDTA K2 GEL TUBES

K-Number: K012043 · 2001-09-24

ApplicantGreiner Vacuette North America, Inc.
Decision Date2001-09-24
Product CodePJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VACUETTE EDTA K2 GEL TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Vacuette North America, Inc.. It received FDA 510(k) clearance on 2001-09-24 under 510(k) number K012043. 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 K2 GEL TUBES?

VACUETTE EDTA K2 GEL TUBES is a medical device that received FDA 510(k) clearance on 2001-09-24. The listed applicant is Greiner Vacuette North America, Inc.. The 510(k) number is K012043.

When did VACUETTE EDTA K2 GEL TUBES receive FDA 510(k) clearance?

VACUETTE EDTA K2 GEL TUBES received FDA 510(k) clearance on 2001-09-24, under 510(k) number K012043.

Who is the listed applicant for VACUETTE EDTA K2 GEL TUBES?

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

What is the FDA product code for VACUETTE EDTA K2 GEL TUBES?

The FDA product code for VACUETTE EDTA K2 GEL 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 Vacuette North America, Inc. 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.

K014104VACUETTE EDTA K2 TUBESK011786VACUETTE SAFETY BLOOD COLLECTION SETK003812VACUETTE SPEEDY QUICK-RELEASE HOLDERK002777VACUETTE WITH PPACK

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 GmbHK042927VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBESGreiner Bio-One Vacuette North AmericaK031359S-MONOVETTE EDTA K2-GELSarstedt, Inc.K014104VACUETTE EDTA K2 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.

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