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Found 2 results

510(k) Data Aggregation

K Number

Device Name

Manufacturer

RADIOMETER MEDICAL A/S

Date Cleared

2000-12-07

(170 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

RADIOMETER MEDICAL A/S

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

Manufacturer

RADIOMETER MEDICAL A/S

Date Cleared

2000-09-13

(48 days)

Product Code

CHL,CEM,CGA,CGZ,CIG,GKF,JFP,JGS,KHP

Regulation Number

Type

Panel

Clinical Chemistry

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

RADIOMETER MEDICAL A/S

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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