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FDA 510(k)

COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS

K-Number: K022550 · 2002-08-27

ApplicantInstrumentation Laboratory CO
Decision Date2002-08-27
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS 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 2002-08-27 under 510(k) number K022550. 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 LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS?

COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS is a medical device that received FDA 510(k) clearance on 2002-08-27. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K022550.

When did COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS receive FDA 510(k) clearance?

COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS received FDA 510(k) clearance on 2002-08-27, under 510(k) number K022550.

Who is the listed applicant for COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS?

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 LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS?

The FDA product code for COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS 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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