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FDA 510(k)

OPUS D-DIMER

K-Number: K972316 · 1997-09-09

ApplicantBehring Diagnostics, Inc.
Decision Date1997-09-09
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OPUS D-DIMER is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-09-09 under 510(k) number K972316. The device is classified under product code GHH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS D-DIMER?

OPUS D-DIMER is a medical device that received FDA 510(k) clearance on 1997-09-09. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K972316.

When did OPUS D-DIMER receive FDA 510(k) clearance?

OPUS D-DIMER received FDA 510(k) clearance on 1997-09-09, under 510(k) number K972316.

Who is the listed applicant for OPUS D-DIMER?

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

What is the FDA product code for OPUS D-DIMER?

The FDA product code for OPUS D-DIMER is GHH.

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Other records listing Behring 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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972116VON WILLEBRAND REAGENTK972011OPUS ETHANOL

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Related Devices (Code: GHH)

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.

K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme LaboratoriesK072288PATHFAST D-DIMERMitsubishi Kagaku IatronK070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLOlympus Life & Material Science Europa GmbH (IrishK062203TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K042890TRIAGE D-DIMER TEST, MODEL 98100Biosite IncorporatedK030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.

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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