FDA 510(k)

SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM

K-Number: K012221 · 2002-04-03

Decision Date2002-04-03

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosafe Laboratories, Inc.. It received FDA 510(k) clearance on 2002-04-03 under 510(k) number K012221. 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 SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM?

SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is Biosafe Laboratories, Inc.. The 510(k) number is K012221.

When did SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM receive FDA 510(k) clearance?

SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM received FDA 510(k) clearance on 2002-04-03, under 510(k) number K012221.

Who is the listed applicant for SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM?

The FDA 510(k) record lists Biosafe Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM?

The FDA product code for SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM is JKA.

Related Clinical Trials

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Other records listing Biosafe Laboratories, Inc. as applicant

K042379ANEMIAPRO SELF-SCREENER K011970BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM K011525SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)K003752BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)K991850SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.