FDA 510(k) Premarket Notification K033631: MODIFICATION TO COATEST FACTOR VIII

Submission Details & Decision

Normalized public record details for 510(k) notification K033631.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K033631

Applicant / Sponsor

Instrumentation Laboratory CO

Device Name

MODIFICATION TO COATEST FACTOR VIII

Product Code

GGP

Decision Date

2003-12-15

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Special

Third Party Flag

Date Received

2003-11-19

Related Establishments / Registrations

INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
HELENA LABORATORIES, CORP. Registration: 1618982 View Registration
CORGENIX, INC. Registration: 1721937 View Registration
R2 DIAGNOSTICS, INC. Registration: 1835316 View Registration
Immucor GTI Diagnostics, Inc. Registration: 2183608 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
CHRONO-LOG CORP. Registration: 2518152 View Registration
AFFINITY BIOLOGICALS INC. Registration: 3003485232 View Registration
BIT Analytical Solutions GmbH Registration: 3003601075 View Registration
BIOMEDICA DIAGNOSTICS INC. Registration: 3003691680 View Registration
ROSSIX AB Registration: 3004075036 View Registration
HYPHEN BIOMED SASU Registration: 3004434070 View Registration
DSRV, INC. Registration: 3004737529 View Registration
TCOAG IRELAND LIMITED Registration: 3008386529 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
Precision BioLogic Inc. Registration: 8043599 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
Diagnostica Stago - Taverny Registration: 9710666 View Registration

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