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FDA 510(k)

BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY

K-Number: K905643 · 1991-04-12

ApplicantAgen Biomedical , Ltd.
Decision Date1991-04-12
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY 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 1991-04-12 under 510(k) number K905643. 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 BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY?

BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Agen Biomedical , Ltd.. The 510(k) number is K905643.

When did BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY receive FDA 510(k) clearance?

BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY received FDA 510(k) clearance on 1991-04-12, under 510(k) number K905643.

Who is the listed applicant for BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY?

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 BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY?

The FDA product code for BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY 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 ASSAYK945642AGEN DIMERTEST GOLD EIAK890189AGEN 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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