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FDA 510(k)

COAMATIC AT-400

K-Number: K022195 · 2002-08-07

ApplicantInstrumentation Laboratory CO
Decision Date2002-08-07
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAMATIC AT-400 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 2002-08-07 under 510(k) number K022195. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAMATIC AT-400?

COAMATIC AT-400 is a medical device that received FDA 510(k) clearance on 2002-08-07. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K022195.

When did COAMATIC AT-400 receive FDA 510(k) clearance?

COAMATIC AT-400 received FDA 510(k) clearance on 2002-08-07, under 510(k) number K022195.

Who is the listed applicant for COAMATIC AT-400?

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 COAMATIC AT-400?

The FDA product code for COAMATIC AT-400 is JBQ.

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Related Devices (Code: JBQ)

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.

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbHK081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare DiagnosticsK070301HEMOSIL ANTITHROMBINInstrumentation Laboratory COK062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory COK043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen BiomedK033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation 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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