FDA 510(k) Premarket Notification K830580: DIAGNON FERRITIN 125 I RIA KIT

Submission Details & Decision

Normalized public record details for 510(k) notification K830580.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K830580

Applicant / Sponsor

Iagnon Corp.

Device Name

DIAGNON FERRITIN 125 I RIA KIT

Product Code

DBF

Decision Date

1983-05-05

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

1983-02-23

Related Establishments / Registrations

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HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
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CTK BIOTECH, INC. Registration: 2032682 View Registration
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BECKMAN COULTER, INC. Registration: 2050010 View Registration
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ALFA WASSERMANN Registration: 2247288 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
HORIBA ABX SAS Registration: 3000148879 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
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ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration
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ACRO BIOTECH Inc. Registration: 3005360469 View Registration
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IDS CO, LTD Registration: 3005655287 View Registration
LUMIQUICK DIAGNOSTICS, INC. Registration: 3005984081 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
Beckman Coulter Biomedical GmbH Registration: 3006677029 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
Kikuyo Factory Registration: 3015969360 View Registration
KENT LABORATORIES, INC. Registration: 3019906 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 View Registration
Siemens Healthcare Diagnostics Manufacturing Ltd. Registration: 8020888 View Registration
TOSOH CORP. Registration: 8031673 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
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