FDA 510(k) Premarket Notification K842125: ALLERCOAT ALLERGEN DISCS

Submission Details & Decision

Normalized public record details for 510(k) notification K842125.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K842125

Applicant / Sponsor

Kallestad Laboratories, Inc.

Device Name

ALLERCOAT ALLERGEN DISCS

Product Code

DGC

Decision Date

1984-06-07

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

1984-05-29

Related Establishments / Registrations

Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
American Laboratory Products Company Registration: 1222302 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
DRG International, Inc. Registration: 2245285 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
Canon Medical Diagnostics USA, Inc. Registration: 2936856 View Registration
Siemens Healthcare Diagnostics Inc Registration: 3002637618 View Registration
DRG INSTRUMENTS GMBH Registration: 3002800697 View Registration
SHIMA LABORATORIES CO., LTD. Registration: 3003985394 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
PHADIA US INC. Registration: 3004973408 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
TOSOH BIOSCIENCE, INC. Registration: 3005529799 View Registration
LUMIQUICK DIAGNOSTICS, INC. Registration: 3005984081 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
THE BINDING SITE Registration: 3012471076 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 View Registration
SUPPLY MAX NY INC Registration: 3033967997 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
TOSOH CORP. Registration: 8031673 View Registration
PHADIA AB Registration: 9610566 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
TOSOH AIA, INC. Registration: 9612316 View Registration
The Binding Site Group Ltd. Registration: 9614373 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 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.