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FDA 510(k)

LITHIUM HEPARINIZED BLOOD COLLECT-TUBE

K-Number: K831242 · 1983-05-16

ApplicantAmerican Dade
Decision Date1983-05-16
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LITHIUM HEPARINIZED BLOOD COLLECT-TUBE is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1983-05-16 under 510(k) number K831242. 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 LITHIUM HEPARINIZED BLOOD COLLECT-TUBE?

LITHIUM HEPARINIZED BLOOD COLLECT-TUBE is a medical device that received FDA 510(k) clearance on 1983-05-16. The listed applicant is American Dade. The 510(k) number is K831242.

When did LITHIUM HEPARINIZED BLOOD COLLECT-TUBE receive FDA 510(k) clearance?

LITHIUM HEPARINIZED BLOOD COLLECT-TUBE received FDA 510(k) clearance on 1983-05-16, under 510(k) number K831242.

Who is the listed applicant for LITHIUM HEPARINIZED BLOOD COLLECT-TUBE?

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

What is the FDA product code for LITHIUM HEPARINIZED BLOOD COLLECT-TUBE?

The FDA product code for LITHIUM HEPARINIZED BLOOD COLLECT-TUBE is JKA.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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