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FDA 510(k)

SIMPLIFY D-DIMER, MODEL DCGK1

K-Number: K993276 · 1999-12-14

ApplicantAgen Biomedical , Ltd.
Decision Date1999-12-14
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIMPLIFY D-DIMER, MODEL DCGK1 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 1999-12-14 under 510(k) number K993276. 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 SIMPLIFY D-DIMER, MODEL DCGK1?

SIMPLIFY D-DIMER, MODEL DCGK1 is a medical device that received FDA 510(k) clearance on 1999-12-14. The listed applicant is Agen Biomedical , Ltd.. The 510(k) number is K993276.

When did SIMPLIFY D-DIMER, MODEL DCGK1 receive FDA 510(k) clearance?

SIMPLIFY D-DIMER, MODEL DCGK1 received FDA 510(k) clearance on 1999-12-14, under 510(k) number K993276.

Who is the listed applicant for SIMPLIFY D-DIMER, MODEL DCGK1?

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 SIMPLIFY D-DIMER, MODEL DCGK1?

The FDA product code for SIMPLIFY D-DIMER, MODEL DCGK1 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.

K974596DIMERTEST LATEX ASSAYK945642AGEN DIMERTEST GOLD EIAK905643BED 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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