FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 2 results

510(k) Data Aggregation

K Number

Device Name

FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

Manufacturer

FUTURE DIAGNOSTICS B.V.

Date Cleared

2001-01-17

(146 days)

Product Code

CKG

Regulation Number

862.1025

Why did this record match?

Applicant Name (Manufacturer) :

FUTURE DIAGNOSTICS B.V.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

K Number

Device Name

FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

Manufacturer

FUTURE DIAGNOSTICS B.V.

Date Cleared

2000-04-11

(57 days)

Product Code

CEW

Regulation Number

862.1545

Why did this record match?

Applicant Name (Manufacturer) :

FUTURE DIAGNOSTICS B.V.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

Page 1 of 1