FDA 510(k) Premarket Notification K914877: IL TEST(TM) UREA NITROGEN

Submission Details & Decision

Normalized public record details for 510(k) notification K914877.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K914877

Applicant / Sponsor

Instrumentation Laboratory CO

Device Name

IL TEST(TM) UREA NITROGEN

Product Code

CDQ

Decision Date

1992-03-11

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1991-10-29

Related Establishments / Registrations

MERCEDES MEDICAL LLC Registration: 1063851 View Registration
Fisher Diagnostics Registration: 1181121 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
MEDICA CORP. Registration: 1220972 View Registration
CURRIER PLASTICS Registration: 1319436 View Registration
STANBIO LABORATORY Registration: 1616487 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
Carolina Liquid Chemistries Corp. Registration: 2030861 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
CLINIQA CORPORATION Registration: 2085064 View Registration
MINDRAY DS USA, Inc. Registration: 2221819 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 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
Infrared Laboratory Systems dba SYNERMED Registration: 3003593973 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
MEDICON HELLAS SA Registration: 3006716639 View Registration
Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration
VitalScientific Registration: 3007662974 View Registration
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3009156722 View Registration
INPECO SA Registration: 3010825766 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
High Technology, Inc. Registration: 3013660430 View Registration
ABBOTT LABORATORIES Registration: 3016438761 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
Sekisui Diagnostics P.E.I. Inc. Registration: 8020316 View Registration
WIENER LABORATORIOS S.A.I.C. Registration: 8040374 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration

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