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FDA 510(k)

PAXgene® Blood DNA Tube

K-Number: K231469 · 2023-06-21

ApplicantPreanalytix GmbH
Decision Date2023-06-21
Product CodePJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PAXgene® Blood DNA Tube is the device name listed in this FDA 510(k) record. The listed applicant is Preanalytix GmbH. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K231469. 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 PAXgene® Blood DNA Tube?

PAXgene® Blood DNA Tube is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Preanalytix GmbH. The 510(k) number is K231469.

When did PAXgene® Blood DNA Tube receive FDA 510(k) clearance?

PAXgene® Blood DNA Tube received FDA 510(k) clearance on 2023-06-21, under 510(k) number K231469.

Who is the listed applicant for PAXgene® Blood DNA Tube?

The FDA 510(k) record lists Preanalytix GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAXgene® Blood DNA Tube?

The FDA product code for PAXgene® Blood DNA Tube 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_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Preanalytix GmbH 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.

K082150MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

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.

K042927VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBESGreiner Bio-One Vacuette North AmericaK031359S-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.

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