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FDA 510(k)

AGEN DIMERTEST GOLD EIA

K-Number: K945642 · 1995-10-25

ApplicantAgen Biomedical , Ltd.
Decision Date1995-10-25
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AGEN DIMERTEST GOLD EIA is the device name listed in this FDA 510(k) record. The listed applicant is Agen Biomedical , Ltd.. It received FDA 510(k) clearance on 1995-10-25 under 510(k) number K945642. 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 AGEN DIMERTEST GOLD EIA?

AGEN DIMERTEST GOLD EIA is a medical device that received FDA 510(k) clearance on 1995-10-25. The listed applicant is Agen Biomedical , Ltd.. The 510(k) number is K945642.

When did AGEN DIMERTEST GOLD EIA receive FDA 510(k) clearance?

AGEN DIMERTEST GOLD EIA received FDA 510(k) clearance on 1995-10-25, under 510(k) number K945642.

Who is the listed applicant for AGEN DIMERTEST GOLD EIA?

The FDA 510(k) record lists Agen Biomedical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGEN DIMERTEST GOLD EIA?

The FDA product code for AGEN DIMERTEST GOLD EIA is GHH.

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Other records listing Agen Biomedical , Ltd. 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.

K993276SIMPLIFY D-DIMER, MODEL DCGK1K974596DIMERTEST LATEX ASSAYK905643BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAYK890189AGEN DIMERTEST EIAK882944DIMERTEST(R) LATEX

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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