JQP · Class I · 21 CFR 862.2100

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
1–24 of 78
Cleared Feb 27, 2012
BIONIME DIABETES MANAGEMENT SYSTEM VI.0
K113007
Bionime Corporation
Chemistry · 143d
Cleared Dec 17, 1998
FASTTAKE ADAPTER, MODEL # P/N 020-072-01
K983468
Selfcare, Inc.
Chemistry · 77d
Cleared Jan 24, 1997
THE ROBOLITE
K964460
Shai Syg Motion and Innovations, Ltd.
Radiology · 78d
Cleared Sep 15, 1995
PRENVAL I
K953652
Base Ten Systems, Inc.
Immunology · 39d
Cleared Nov 02, 1994
MR7000 WITH TIME MANAGER SOFTWARE (TMS)
K934111
Dynatech Laboratories, Inc.
Microbiology · 456d
Cleared Feb 23, 1993
EXPRESSO CARTRIDGE
K923316
Bio-Rad Laboratories, Inc.
Chemistry · 231d
Cleared Aug 31, 1989
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
K893838
Ciba Corning Diagnostics Corp.
Chemistry · 99d
Cleared Aug 10, 1989
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
K892060
Syva Co.
Chemistry · 134d
Cleared Mar 22, 1989
COBAS MFC
K885292
Roche Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jun 01, 1988
RIA-QUICK
K881194
Quantitative Technologies, Inc.
Chemistry · 72d
Cleared Jul 16, 1987
V-MARC 88A COMPUTER
K871853
V.Marc, A Div. of Pictorial, Inc.
Chemistry · 65d
Cleared May 15, 1987
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM
K871339
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 43d
Cleared Feb 25, 1987
710 PLUS
K864557
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Aug 12, 1986
GLUCOFACTS DATA MANAGEMENT SYSTEM
K861844
Miles Laboratories, Inc.
Chemistry · 91d
Cleared Aug 08, 1986
GLUCOFACTS DATA PRINTER
K861779
Miles Laboratories, Inc.
Chemistry · 92d
Cleared Jul 02, 1986
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
K861778
Miles Laboratories, Inc.
Chemistry · 55d
Cleared May 23, 1986
DIRECT READOUT MODULE ACCESSORY
K861412
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 38d
Cleared Mar 18, 1986
SIMULATOR
K854265
Cygnus of South Florida, Inc.
General Hospital · 146d
Cleared Aug 02, 1985
BIOVATION MAX DATA MANAGEMENT SYSTEM
K853026
Biovation, Inc.
Chemistry · 15d
Cleared Apr 25, 1985
ATAC 2000 CHEMISTRY ANALYZER
K851321
Turpen Laboratory Systems, Inc.
Chemistry · 23d
Cleared Apr 01, 1985
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
K850659
Syva Co.
Toxicology · 40d
Cleared Jan 18, 1985
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
K844907
Miles Laboratories, Inc.
Chemistry · 32d
Cleared Sep 27, 1984
ISO-DATA IMMUNOASSAY NETWORK SYSTEM
K843365
Iso-Data, Inc.
Chemistry · 30d
Cleared Sep 04, 1984
CHEMISTRY CONSOLE
K842401
Biovation, Inc.
Chemistry · 77d

About Product Code JQP - Regulatory Context