FDA 510(k) Premarket Notification K091556: HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS

Submission Details & Decision

Normalized public record details for 510(k) notification K091556.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K091556

Applicant / Sponsor

Instrumentation Laboratory CO

Device Name

HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS

Product Code

MSV

Decision Date

2010-05-21

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

2009-05-27

Related Establishments / Registrations

HEMAGEN DIAGNOSTICS, INC. Registration: 1181055 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
American Laboratory Products Company Registration: 1222302 View Registration
THERATEST LABORATORIES, INC. Registration: 1421346 View Registration
LOUISVILLE APL DIAGNOSTICS, INC. Registration: 1529254 View Registration
CORGENIX, INC. Registration: 1721937 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
INOVA DIAGNOSTICS, INC. Registration: 2026994 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
AESKU.DIAGNOSTICS GmbH&Co.KG Registration: 3003825930 View Registration
PHADIA US INC. Registration: 3004973408 View Registration
INSTRUMENTATION LABORATORY SPA Registration: 3012348571 View Registration
BIO-RAD LABORATORIES, INC. Registration: 3032705 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
PHADIA AB Registration: 3039353646 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
PHADIA AB Registration: 9610566 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
PHADIA GMBH Registration: 9680745 View Registration

Public Record Disclaimer

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 Information may be outdated or incomplete.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.