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FDA 510(k)

MINUTEX D-DIMER LATEX TEST

K-Number: K920668 · 1992-10-16

ApplicantBiopool AB
Decision Date1992-10-16
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MINUTEX D-DIMER LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is Biopool AB. It received FDA 510(k) clearance on 1992-10-16 under 510(k) number K920668. 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 MINUTEX D-DIMER LATEX TEST?

MINUTEX D-DIMER LATEX TEST is a medical device that received FDA 510(k) clearance on 1992-10-16. The listed applicant is Biopool AB. The 510(k) number is K920668.

When did MINUTEX D-DIMER LATEX TEST receive FDA 510(k) clearance?

MINUTEX D-DIMER LATEX TEST received FDA 510(k) clearance on 1992-10-16, under 510(k) number K920668.

Who is the listed applicant for MINUTEX D-DIMER LATEX TEST?

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

What is the FDA product code for MINUTEX D-DIMER LATEX TEST?

The FDA product code for MINUTEX D-DIMER LATEX TEST is GHH.

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Other records listing Biopool AB 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.

K941752SPECTROLYSE ANTIPLASMIN KITK942087BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATESK934314TINTELIZER(R) TPAK923499SPECTROLYSE HEPARIN KITK932463BIOCLOT LAK922782SPECTROLYSE/PL PAI KIT

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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

View on FDA Database →

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

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