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Found 5 results

510(k) Data Aggregation

K Number

Device Name

ORTHO VLC; ORTHO VLC CAPSULE

Manufacturer

FIRST SCIENTIFIC LIMITED

Date Cleared

2001-08-01

(76 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

FIRST SCIENTIFIC LIMITED

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

Manufacturer

FIRST SCIENTIFIC LIMITED

Date Cleared

2001-07-23

(67 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

FIRST SCIENTIFIC LIMITED

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

Manufacturer

FIRST SCIENTIFIC LIMITED

Date Cleared

2001-07-10

(54 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

FIRST SCIENTIFIC LIMITED

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

RESTORE-PF VIC; RESTORE-PF VLC CAPSULE

Manufacturer

FIRST SCIENTIFIC LIMITED

Date Cleared

2001-06-27

(58 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

FIRST SCIENTIFIC LIMITED

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

LUTE VLC; CORE VLC

Manufacturer

FIRST SCIENTIFIC LIMITED

Date Cleared

2001-06-22

(53 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

FIRST SCIENTIFIC LIMITED

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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