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FDA 510(k)

ACTICHROME ATIII KIT

K-Number: K893608 · 1989-06-23

ApplicantAmerican Diagnostic Corp.
Decision Date1989-06-23
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACTICHROME ATIII KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K893608. 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 ACTICHROME ATIII KIT?

ACTICHROME ATIII KIT is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is American Diagnostic Corp.. The 510(k) number is K893608.

When did ACTICHROME ATIII KIT receive FDA 510(k) clearance?

ACTICHROME ATIII KIT received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893608.

Who is the listed applicant for ACTICHROME ATIII KIT?

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

What is the FDA product code for ACTICHROME ATIII KIT?

The FDA product code for ACTICHROME ATIII KIT is JBQ.

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Other records listing American Diagnostic Corp. as applicant

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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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