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FDA 510(k)

DIMERTEST LATEX

K-Number: K842277 · 1985-04-03

ApplicantMabco, Inc.
Decision Date1985-04-03
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIMERTEST LATEX is the device name listed in this FDA 510(k) record. The listed applicant is Mabco, Inc.. It received FDA 510(k) clearance on 1985-04-03 under 510(k) number K842277. 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 DIMERTEST LATEX?

DIMERTEST LATEX is a medical device that received FDA 510(k) clearance on 1985-04-03. The listed applicant is Mabco, Inc.. The 510(k) number is K842277.

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

DIMERTEST LATEX received FDA 510(k) clearance on 1985-04-03, under 510(k) number K842277.

Who is the listed applicant for DIMERTEST LATEX?

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

What is the FDA product code for DIMERTEST LATEX?

The FDA product code for DIMERTEST LATEX is GHH.

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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

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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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