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FDA 510(k)

APPRAISE-CARDIO SAMPLE COLLECTION KIT

K-Number: K993787 · 2000-04-14

ApplicantOsborn Group, Inc.
Decision Date2000-04-14
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APPRAISE-CARDIO SAMPLE COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Osborn Group, Inc.. It received FDA 510(k) clearance on 2000-04-14 under 510(k) number K993787. 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 APPRAISE-CARDIO SAMPLE COLLECTION KIT?

APPRAISE-CARDIO SAMPLE COLLECTION KIT is a medical device that received FDA 510(k) clearance on 2000-04-14. The listed applicant is Osborn Group, Inc.. The 510(k) number is K993787.

When did APPRAISE-CARDIO SAMPLE COLLECTION KIT receive FDA 510(k) clearance?

APPRAISE-CARDIO SAMPLE COLLECTION KIT received FDA 510(k) clearance on 2000-04-14, under 510(k) number K993787.

Who is the listed applicant for APPRAISE-CARDIO SAMPLE COLLECTION KIT?

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

What is the FDA product code for APPRAISE-CARDIO SAMPLE COLLECTION KIT?

The FDA product code for APPRAISE-CARDIO SAMPLE COLLECTION KIT 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.

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Other records listing Osborn Group, Inc. 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.

K002156APPRAISE URINE MICROALBUMIN COLLECTION KITK990899HEMOCHEK-A1C SAMPLE COLLECTION KITK991800HEMOCHEK URINE COLLECTION KIT

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

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

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