FDA 510(k) Premarket Notification K881300: MAGNESIUM LIQUID STABLE REAGENT SET

Submission Details & Decision

Normalized public record details for 510(k) notification K881300.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K881300

Applicant / Sponsor

Medical Analysis Systems, Inc.

Device Name

MAGNESIUM LIQUID STABLE REAGENT SET

Product Code

JGJ

Decision Date

1988-05-17

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1988-03-28

Related Establishments / Registrations

NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER Registration: 1000403749 View Registration
Fisher Diagnostics Registration: 1181121 View Registration
Viant AS&O Holdings, LLC Registration: 1218882 View Registration
MEDICA CORP. Registration: 1220972 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319808 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319809 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
ALFA WASSERMANN Registration: 2247288 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
ABAXIS, INC. Registration: 2939693 View Registration
HORIBA ABX SAS Registration: 3000148879 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
Infrared Laboratory Systems dba SYNERMED Registration: 3003593973 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
FURUNO ELECTRIC CO., LTD. Registration: 3004438098 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
VitalScientific Registration: 3007662974 View Registration
Randox Teoranta Registration: 3009473156 View Registration
INPECO SA Registration: 3010825766 View Registration
Microgenics Corporation Registration: 3010939897 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
High Technology, Inc. Registration: 3013660430 View Registration
RANDOX LABORATORIES LIMITED Registration: 3014607865 View Registration
ABBOTT LABORATORIES Registration: 3016438761 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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