FDA 510(k) Premarket Notification K954575: AXSYM TOXO IGG ANTIBODY ASSAY

Submission Details & Decision

Normalized public record details for 510(k) notification K954575.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K954575

Applicant / Sponsor

Abbott Laboratories

Device Name

AXSYM TOXO IGG ANTIBODY ASSAY

Product Code

LGD

Decision Date

1996-08-16

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

1995-10-02

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
Trinity Biotech USA Registration: 1318354 View Registration
ARLINGTON SCIENTIFIC, INC. Registration: 1641328 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
MONOBIND, INC. Registration: 2020726 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
CALBIOTECH, INC. Registration: 2090110 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
ZEUS SCIENTIFIC LLC Registration: 2242436 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
DIAMOND DIAGNOSTICS Inc Registration: 3003030793 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
GOLD STANDARD DIAGNOSTICS, LLC Registration: 3007208259 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 View Registration
BOSTON EASY BIOTECH INC Registration: 3024753119 View Registration
BIO-RAD LABORATORIES, INC. Registration: 3032705 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
Bio-Rad Service France SAS Registration: 3035708936 View Registration
BIOMERIEUX SA Registration: 8020790 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
BIO-RAD Registration: 8023060 View Registration
TOSOH CORP. Registration: 8031673 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
DiaSorin Italia S.p.A. Registration: 9610240 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration
BIOMERIEUX ITALIA-INDUSTRIAL DIV. Registration: 9615037 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.