FDA 510(k)

MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR

K-Number: K853152 · 1985-08-23

Decision Date1985-08-23

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1985-08-23 under 510(k) number K853152. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR?

MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR is a medical device that received FDA 510(k) clearance on 1985-08-23. The listed applicant is Sherwood Medical Co.. The 510(k) number is K853152.

When did MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR receive FDA 510(k) clearance?

MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR received FDA 510(k) clearance on 1985-08-23, under 510(k) number K853152.

Who is the listed applicant for MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR?

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

What is the FDA product code for MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR?

The FDA product code for MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR is JKA.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sherwood Medical Co. as applicant

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS K960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA K962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM K960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM K960677KANGAROO JEJUNAL FEEDING SYSTEM K960632KANGAROO FEEDING TUBE PLACMENT STYLET

View all 191 devices →

Related Devices (Code: JKA)

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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.