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FDA 510(k)

DIMERTEST(R) LATEX

K-Number: K882944 · 1988-08-17

ApplicantAgen Biomedical , Ltd.
Decision Date1988-08-17
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIMERTEST(R) LATEX 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 1988-08-17 under 510(k) number K882944. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMERTEST(R) LATEX?

DIMERTEST(R) LATEX is a medical device that received FDA 510(k) clearance on 1988-08-17. The listed applicant is Agen Biomedical , Ltd.. The 510(k) number is K882944.

When did DIMERTEST(R) LATEX receive FDA 510(k) clearance?

DIMERTEST(R) LATEX received FDA 510(k) clearance on 1988-08-17, under 510(k) number K882944.

Who is the listed applicant for DIMERTEST(R) LATEX?

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 DIMERTEST(R) LATEX?

The FDA product code for DIMERTEST(R) LATEX is DAP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 EIAK905643BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAYK890189AGEN DIMERTEST EIA

Related Devices (Code: DAP)

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.

K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbHK172903HemosIL D-Dimer HS 500Instrumentation Laboratory COK162227STA® - Liatest® D-DiDiagnostica StagoK160885HemosIL D-Dimer HSInstrumentation Laboratory COK112818VIDAS D-DIMER EXCLUSION II (DEX2)bioMerieux, Inc.K110303STRATUS CS ACUTE CARE D-DIMERSiemens Healthcare Diagnostics

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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