FDA Product Code JQP: Calculator/data Processing Module, For Clinical Use
Leading manufacturers include Miles Laboratories, Inc., Syva Co. and Instrumentation Laboratory CO.
78
Total
78
Cleared
64d
Avg days
1976
Since
FDA 510(k) Cleared Calculator/data Processing Module, For Clinical Use Devices (Product Code JQP)
78 devices
Cleared
Feb 27, 2012
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Chemistry
143d
Cleared
Dec 17, 1998
FASTTAKE ADAPTER, MODEL # P/N 020-072-01
Selfcare, Inc.
Chemistry
77d
Cleared
Jan 24, 1997
THE ROBOLITE
Shai Syg Motion and Innovations, Ltd.
Radiology
78d
Cleared
Sep 15, 1995
PRENVAL I
Base Ten Systems, Inc.
Immunology
39d
Cleared
Nov 02, 1994
MR7000 WITH TIME MANAGER SOFTWARE (TMS)
Dynatech Laboratories, Inc.
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456d
Cleared
Feb 23, 1993
EXPRESSO CARTRIDGE
Bio-Rad Laboratories, Inc.
Chemistry
231d
Cleared
Aug 31, 1989
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
Ciba Corning Diagnostics Corp.
Chemistry
99d
Cleared
Aug 10, 1989
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
Syva Co.
Chemistry
134d
Cleared
Mar 22, 1989
COBAS MFC
Roche Diagnostic Systems, Inc.
Chemistry
85d
Cleared
Jun 01, 1988
RIA-QUICK
Quantitative Technologies, Inc.
Chemistry
72d
Cleared
Jul 16, 1987
V-MARC 88A COMPUTER
V.Marc, A Div. of Pictorial, Inc.
Chemistry
65d
Cleared
May 15, 1987
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology
43d
Cleared
Feb 25, 1987
710 PLUS
Ciba Corning Diagnostics Corp.
Chemistry
98d
Cleared
Aug 12, 1986
GLUCOFACTS DATA MANAGEMENT SYSTEM
Miles Laboratories, Inc.
Chemistry
91d
Cleared
Aug 08, 1986
GLUCOFACTS DATA PRINTER
Miles Laboratories, Inc.
Chemistry
92d
Cleared
Jul 02, 1986
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
Miles Laboratories, Inc.
Chemistry
55d
Cleared
May 23, 1986
DIRECT READOUT MODULE ACCESSORY
E.I. Dupont DE Nemours & Co., Inc.
Chemistry
38d
Cleared
Mar 18, 1986
SIMULATOR
Cygnus of South Florida, Inc.
General Hospital
146d
Cleared
Aug 02, 1985
BIOVATION MAX DATA MANAGEMENT SYSTEM
Biovation, Inc.
Chemistry
15d
Cleared
Apr 25, 1985
ATAC 2000 CHEMISTRY ANALYZER
Turpen Laboratory Systems, Inc.
Chemistry
23d
Cleared
Apr 01, 1985
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
Syva Co.
Toxicology
40d
Cleared
Jan 18, 1985
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
Miles Laboratories, Inc.
Chemistry
32d
Cleared
Sep 27, 1984
ISO-DATA IMMUNOASSAY NETWORK SYSTEM
Iso-Data, Inc.
Chemistry
30d
Cleared
Sep 04, 1984
CHEMISTRY CONSOLE
Biovation, Inc.
Chemistry
77d