JQP

Product Code: JQP


Products Classified as JQP

564Calculator/data Processing Module, For Clinical UseCalculator/data Processing Module For Clinical Use.

Total Product Life Cycle (TPLC) Devices

564Calculator/data Processing Module, For Clinical UseCalculator/data Processing Module For Clinical Use.

FDA Consensus Standards

Calculator/Data Processing Module, For Clinical Use [22440]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [22458]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [34908]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [22448]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [22462]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [22466]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [22446]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [32429]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [32431]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [31244]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [22464]21 CFR §862.2100 🔎
Calculator/Data Processing Module, For Clinical Use [25908]21 CFR §862.2100 🔎

Pre-market Notifications for JQP

K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.0BIONIME CORPORATION
K983468FASTTAKE ADAPTER, MODEL # P/N 020-072-01SELFCARE, INC.
K964460THE ROBOLITESHAI SYG MOTION AND INNOVATIONS, LTD.
K953652PRENVAL IBASE TEN SYSTEMS, INC.
K934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)DYNATECH LABORATORIES, INC.
K923316EXPRESSO CARTRIDGEBIO-RAD LABORATORIES, INC.
K893838MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZERCIBA CORNING DIAGNOSTICS CORP.
K881194RIA-QUICKQUANTITATIVE TECHNOLOGIES, INC.
K871853V-MARC 88A COMPUTERV.MARC, A DIV. OF PICTORIAL, INC.
K871339KALLESTAD QM300 PROTEIN ANALYSIS SYSTEMKALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
K861844GLUCOFACTS DATA MANAGEMENT SYSTEMMILES LABORATORIES, INC.
K861778CLINIFACTS 200 DATA MANAGEMENT SYSTEMMILES LABORATORIES, INC.
K861779GLUCOFACTS DATA PRINTERMILES LABORATORIES, INC.
K861412DIRECT READOUT MODULE ACCESSORYE.I. DUPONT DE NEMOURS & CO., INC.
K853026BIOVATION MAX DATA MANAGEMENT SYSTEMBIOVATION, INC.

Global Unique Device Identification Database

00382904410070CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
00380740158255CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
00380740145118Calculator/data processing module, for clinical use
00301933515013Calculator/Data Processing Module, For Clinical Use
00630414001975CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
00682607001118CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
20883489001461Calculator/Data Processing Module, For Clinical Use
20883489001485Calculator/Data Processing Module, For Clinical Use
00859519002247Calculator/Data Processing Module, For Clinical Use
00859474006274Calculator/Data Processing Module, For Clinical Use
00859474006199Calculator/Data Processing Module, For Clinical Use
00859474006076Calculator/Data Processing Module, For Clinical Use
00853023006159Calculator/Data Processing Module, For Clinical Use
06438147352401Calculator/Data Processing Module, For Clinical Use
06438147320905Calculator/Data Processing Module, For Clinical Use

Maude Adverse Events

SYNGO LAB CONECTIVITY MANAGERSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-30
SYS-MYLA?BIOMERIEUX, SA2020-03-25
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2020-03-19
ALINIQ AMSABBOTT S.R.L.2020-03-10
INSTRUMENT MANAGERDATA INNOVATIONS LLC2020-02-28
COBAS P 471 CENTRIFUGE UNITROCHE DIAGNOSTICS2020-02-21
COBAS 8100ROCHE DIAGNOSTICS2020-02-12
SPECIMEN GATE LABORATORYWALLAC OY, SUBSIDIARY OF PERKINELMER2020-02-05
REMISOL ADVANCE (RADV)NORMAND-INFO S.A.S.U.2020-01-22
MODULAR PRE-ANALYTICSROCHE DIAGNOSTICS2020-01-21
CENTRALINK DATA MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-01-10
CENTRALINK DATA MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-01-10
SYS-MYLA? - 4700384BIOMERIEUX, SA2020-01-10
COBAS P 612 PRE-ANALYTICAL SYSTEMROCHE DIAGNOSTICS2019-12-02
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-11-27
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-11-21
CENTRALINK DATA MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-11-20
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-11-13
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-11-13
INSTRUMENT MANAGER SOFTWAREDATA INNOVATIONS LLC2019-11-08
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-11-08
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-10-30
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-10-28
REMISOL ADVANCE VIRTUALIZED SERVER 2012NORMAND-INFO S.A.S.U2019-10-08
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-09-11
INSTRUMENT MANAGER SOFTWAREDATA INNOVATIONS LLC2019-09-09
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-09-09
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-09-03
CENTRALINK DATA MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2019-08-27
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-08-23
STARLIMS CLINICAL SOLUTIONABBOTT INFORMATICS CORPORATION2019-08-21
COBAS P 512 PRE-ANALYTICAL SYSTEMROCHE DIAGNOSTICS2019-08-20
COBAS INFINITY CORE SOFTWAREROCHE DIAGNOSTICS2019-08-16
ALINIQ AMSABBOTT S.R.L.2019-08-15
ALINIQ AMSABBOTT S.R.L.2019-08-13
ACCELERATOR APS CENTRIFUGE MODULEABBOTT MANUFACTURING INC2019-08-07
ACCELERATOR APS INPUT OUTPUT MODULEABBOTT MANUFACTURING INC2019-08-07
MPAAUTOMATED PREANALYTICAL SYSTEMROCHE DIAGNOSTICS2019-08-07
CENTRALINK DATA MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2019-08-05
CENTRALINK DATA MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2019-08-05
CENTRALINK DATA MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2019-08-05
COBAS 8100ROCHE DIAGNOSTICS INTERNATIONAL LTD.2019-07-25
SYNGO LAB DATA MANAGERSIEMENS HEALTHCARE DIAGNOSTICS INC.2019-07-25
SYNGO LAB DATA MANAGERSIEMENS HEALTHCARE DIAGNOSTICS INC.2019-07-24
COAGUCHEK INR MACHINEROCHE DIAGNOSTICS GMBH / ROCHE DIAGNOSTICS OPERATIONS, INC.2019-07-23
CENTRALINK DATA MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2019-07-18
CENTRALINK DATA MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2019-07-12
CENTRALINK DATA MANAGEMENT SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS INC.2019-07-12
ACCELERATOR APS CENTRIFUGE MODULEABBOTT MANUFACTURING INC2019-07-11
ACCELERATOR APS CENTRIFUGE MODULEABBOTT MANUFACTURING INC2019-07-11

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