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FDA 510(k)

MONOJET SPS BLOOD COLLECTION TUBE

K-Number: K831719 · 1983-07-18

ApplicantSherwood Medical Co.
Decision Date1983-07-18
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MONOJET SPS BLOOD COLLECTION TUBE 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 1983-07-18 under 510(k) number K831719. 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 MONOJET SPS BLOOD COLLECTION TUBE?

MONOJET SPS BLOOD COLLECTION TUBE is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Sherwood Medical Co.. The 510(k) number is K831719.

When did MONOJET SPS BLOOD COLLECTION TUBE receive FDA 510(k) clearance?

MONOJET SPS BLOOD COLLECTION TUBE received FDA 510(k) clearance on 1983-07-18, under 510(k) number K831719.

Who is the listed applicant for MONOJET SPS BLOOD COLLECTION TUBE?

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 MONOJET SPS BLOOD COLLECTION TUBE?

The FDA product code for MONOJET SPS BLOOD COLLECTION TUBE is JKA.

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Other records listing Sherwood Medical Co. 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.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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Related Devices (Code: JKA)

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.

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 CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD 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.

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