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FDA 510(k)

ACL TOP MODEL, TOP

K-Number: K033414 · 2004-01-12

ApplicantInstrumentation Laboratory CO
Decision Date2004-01-12
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACL TOP MODEL, TOP is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2004-01-12 under 510(k) number K033414. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACL TOP MODEL, TOP?

ACL TOP MODEL, TOP is a medical device that received FDA 510(k) clearance on 2004-01-12. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K033414.

When did ACL TOP MODEL, TOP receive FDA 510(k) clearance?

ACL TOP MODEL, TOP received FDA 510(k) clearance on 2004-01-12, under 510(k) number K033414.

Who is the listed applicant for ACL TOP MODEL, TOP?

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

What is the FDA product code for ACL TOP MODEL, TOP?

The FDA product code for ACL TOP MODEL, TOP is GKP.

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Other records listing Instrumentation Laboratory 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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Related Devices (Code: GKP)

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.

K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)Instrumentation Laboratory (IL) Co.K231031ACL TOP Family 70 SeriesInstrumentation Laboratory CompanyK160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)Instrumentation Laboratory COK091980ACL TOP 700 LASInstrumentation Laboratory COK073377ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)Instrumentation Laboratory COK063679ACL TOPInstrumentation Laboratory CO

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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