FDA 510(k) Premarket Notification K934605: STAGO FACTOR V-DEFICIENT PLASMA

Submission Details & Decision

Normalized public record details for 510(k) notification K934605.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K934605

Applicant / Sponsor

American Bioproducts Co.

Device Name

STAGO FACTOR V-DEFICIENT PLASMA

Product Code

GJT

Decision Date

1994-03-01

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Hematology (HE)

Clearance Type

Traditional

Third Party Flag

Date Received

1993-09-27

Related Establishments / Registrations

Fisher Diagnostics Registration: 1181121 View Registration
DIAPHARMA GROUP, INC. Registration: 1530434 View Registration
R2 DIAGNOSTICS, INC. Registration: 1835316 View Registration
GEORGE KING BIO-MEDICAL, INC. Registration: 1928890 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 View Registration
TCOAG IRELAND LIMITED Registration: 3008386529 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
Precision BioLogic Inc. Registration: 8043599 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
Diagnostica Stago - Taverny Registration: 9710666 View Registration

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