FDA 510(k) Premarket Notification K980242: IL TEST HEPARIN

Submission Details & Decision

Normalized public record details for 510(k) notification K980242.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K980242

Applicant / Sponsor

Instrumentation Laboratory CO

Device Name

IL TEST HEPARIN

Product Code

KFF

Decision Date

1998-03-19

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Traditional

Third Party Flag

Date Received

1998-01-23

Related Establishments / Registrations

INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
HELENA LABORATORIES, CORP. Registration: 1618982 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 View Registration
Accriva Diagnostics, Inc. Registration: 3002721930 View Registration
BIOMEDICA DIAGNOSTICS INC. Registration: 3003691680 View Registration
HYPHEN BIOMED SASU Registration: 3004434070 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
Diagnostica Stago - Taverny Registration: 9710666 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.