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FDA 510(k)

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM

K-Number: K221359 · 2023-09-29

ApplicantInstrumentation Laboratory CO
Decision Date2023-09-29
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM is a medical device manufactured by Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2023-09-29 under approval number K221359. 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, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM?

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Instrumentation Laboratory CO. The 510(k) number is K221359.

When was ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM approved by the FDA?

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM received FDA 510(k) clearance on 2023-09-29, under approval number K221359.

What company makes ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM?

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM is manufactured by Instrumentation Laboratory CO.

What is the FDA product code for ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM?

The FDA product code for ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM is JPA.

Other Devices by Instrumentation Laboratory CO

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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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