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FDA 510(k)

ACL TOP 970 CL

K-Number: K233790 · 2023-12-29

ApplicantInstrumentation Laboratory
Decision Date2023-12-29
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACL TOP 970 CL is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory. It received FDA 510(k) clearance on 2023-12-29 under 510(k) number K233790. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACL TOP 970 CL?

ACL TOP 970 CL is a medical device that received FDA 510(k) clearance on 2023-12-29. The listed applicant is Instrumentation Laboratory. The 510(k) number is K233790.

When did ACL TOP 970 CL receive FDA 510(k) clearance?

ACL TOP 970 CL received FDA 510(k) clearance on 2023-12-29, under 510(k) number K233790.

Who is the listed applicant for ACL TOP 970 CL?

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

What is the FDA product code for ACL TOP 970 CL?

The FDA product code for ACL TOP 970 CL is JPA.

Other records listing Instrumentation Laboratory 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.

K230852HemosIL Chromogenic Factor IXK221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223608GEM Premier 7000 with IQM3K223187HemosIL Liquid Anti-XaK231031ACL TOP Family 70 SeriesK223090GEM Premier ChemSTAT

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Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation 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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