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Found 5 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY

Manufacturer

SOLARCARE TECHNOLOGIES CORP,INC.

Date Cleared

1996-07-23

(312 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY

Manufacturer

SOLARCARE TECHNOLOGIES CORP,INC.

Date Cleared

1996-07-22

(321 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY

Manufacturer

SOLARCARE TECHNOLOGIES CORP,INC.

Date Cleared

1996-05-30

(153 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

STC DIAGNOSTICS AUTO-LYTE PH ASSAY

Manufacturer

SOLARCARE TECHNOLOGIES CORP,INC.

Date Cleared

1996-04-30

(238 days)

Product Code

Regulation Number

Type

Panel

Clinical Chemistry

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION

Manufacturer

SOLARCARE TECHNOLOGIES CORP,INC.

Date Cleared

1996-03-19

(804 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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