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FDA 510(k)

ASSAY, CHROMOGENIC ANTITHROMBIN III

K-Number: K781860 · 1978-12-04

ApplicantOrtho Diagnostics, Inc.
Decision Date1978-12-04
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ASSAY, CHROMOGENIC ANTITHROMBIN III is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostics, Inc.. It received FDA 510(k) clearance on 1978-12-04 under 510(k) number K781860. 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 ASSAY, CHROMOGENIC ANTITHROMBIN III?

ASSAY, CHROMOGENIC ANTITHROMBIN III is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K781860.

When did ASSAY, CHROMOGENIC ANTITHROMBIN III receive FDA 510(k) clearance?

ASSAY, CHROMOGENIC ANTITHROMBIN III received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781860.

Who is the listed applicant for ASSAY, CHROMOGENIC ANTITHROMBIN III?

The FDA 510(k) record lists Ortho Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSAY, CHROMOGENIC ANTITHROMBIN III?

The FDA product code for ASSAY, CHROMOGENIC ANTITHROMBIN III is JBQ.

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Other records listing Ortho Diagnostics, Inc. 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.

K802404ORTHO BOVINE ALBUMIN SOLUTION 30% PROTEK801507ANTIGEN CONTROL CELLSK800357BI-LEVEL ASSAYED CARD. DRUG CONT., I,IIK800310ORTHO ANTISERA CONTROLK791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONK791301ORTHO TSH RIA KIT

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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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