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)

NORTH BLOODBORNE PATHOGEN RESPONSE KIT

K-Number: K950554 · 1995-06-28

ApplicantNorth Safety Products
Decision Date1995-06-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NORTH BLOODBORNE PATHOGEN RESPONSE KIT is the device name listed in this FDA 510(k) record. The listed applicant is North Safety Products. It received FDA 510(k) clearance on 1995-06-28 under 510(k) number K950554. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTH BLOODBORNE PATHOGEN RESPONSE KIT?

NORTH BLOODBORNE PATHOGEN RESPONSE KIT is a medical device that received FDA 510(k) clearance on 1995-06-28. The listed applicant is North Safety Products. The 510(k) number is K950554.

When did NORTH BLOODBORNE PATHOGEN RESPONSE KIT receive FDA 510(k) clearance?

NORTH BLOODBORNE PATHOGEN RESPONSE KIT received FDA 510(k) clearance on 1995-06-28, under 510(k) number K950554.

Who is the listed applicant for NORTH BLOODBORNE PATHOGEN RESPONSE KIT?

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

What is the FDA product code for NORTH BLOODBORNE PATHOGEN RESPONSE KIT?

The FDA product code for NORTH BLOODBORNE PATHOGEN RESPONSE KIT is FXX.

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

Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

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.

↑