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Panels › Clinical Chemistry › Product code JJX · Class 1

Single (Specified) Analyte Controls (Assayed And Unassayed)

Regulation 862.1660

0510(k)s in 12 months (493 all time)
0recalls in 12 months (42 all time)
32recalls that name a 510(k)
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Top companies in JJX

Company510(k)sRecalls
Roche Diagnostics600
Siemens Healthcare Diagnostics346
Boehringer Mannheim Corp.240
Bionostics, Inc.220
Bio-Rad210
Ortho-Clinical Diagnostics133
Abbott Laboratories49
Beckman Coulter, Inc.94
Casco Standards100
Tosoh Medics, Inc.100
Decided510(k)Device and applicantCode
Jul 30, 1992K922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II
Reagents Applications, Inc.
JJX
Jul 17, 1992K921252TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
Hybritech, Inc.
JJX
Jul 17, 1992K920556TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET
Hybritech, Inc.
JJX
Apr 29, 1992K921206HCG CONTROL
Polymedco, Inc.
JJX
Apr 29, 1992K921089LYPHOCHEK(R) FRUCTOSAMINE CONTROL
Bio-Rad
JJX
Mar 2, 1992K915325TSH CONTROL
Polymedco, Inc.
JJX
Jan 30, 1992K915806MILENIA DATA REDUCTION
Diagnostic Products Corp.
JJX
Jan 27, 1992K914809MP MINI PHOTOMETER
Artel, Inc.
JJX
Oct 21, 1991K913585LIPASE LINEARITY CONTROL
Creative Laboratory Products, Inc.
JJX
Sep 25, 1991K913792HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL
Hichem Diagnostics
JJX
Sep 25, 1991K913346QUANTIMETRIX AMMONIA CONTROLS
Quantimetrix Corp.
JJX
Sep 11, 1991K913496CHOLINESTERASE LINEARITY CONTROL
Creative Laboratory Products, Inc.
JJX
Aug 28, 1991K912439TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
Hybritech, Inc.
JJX
May 31, 1991K911664DIRECTIGEN 1-2-3 PREGNANCY CONTROLS
Quidel Corp.
JJX
May 1, 1991K911178ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III
Analytical Control Systems, Inc.
JJX
May 1, 1991K911177ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II
Analytical Control Systems, Inc.
JJX
May 1, 1991K911176ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I
Analytical Control Systems, Inc.
JJX
Feb 4, 1991K905280BIOTROL BILIRUBIN C & T CONTROL
Biotrol, USA, Inc.
JJX
Nov 2, 1990K904503SERACON CR REFERENCE
Bhp Diagnostix, Inc.
JJX
Oct 15, 1990K904306DUPONT DRUG CALIBRATOR-A
E.I. Dupont DE Nemours & Co., Inc.
JJX
Aug 9, 1990K903147CHEM-CHEX-ALT
Streck Laboratories, Inc.
JJX
Aug 9, 1990K902569PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF
Boehringer Mannheim Corp.
JJX
Jul 27, 1990K902760AMERSHAM TSH CONTROL SERA
Amersham Corp.
JJX
Jul 16, 1990K902867CHEM-CHEX BILIRUBIN
Streck Laboratories, Inc.
JJX
May 30, 1990K900719ROTAG CONTROLS
Roche Diagnostic Systems, Inc.
JJX
Feb 26, 1990K896875POSITIVE AND NEGATIVE HCG SERUM CONTROLS
Armkel, LLC
JJX
Oct 25, 1989K895528GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
Helena Laboratories
JJX
Oct 23, 1989K894400MICRO-PLATE READER, MDX-1
Medix Biotech, Inc.
JJX
Sep 28, 1989K894804SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
Lifescan, Inc.
JJX
Sep 5, 1989K894329RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
Amersham Corp.
JJX
Aug 31, 1989K894181POSITIVE AND NEGATIVE HCG URINE CONTROLS
Armkel, LLC
JJX
Aug 1, 1989K891475LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
Bio-Rad
JJX
Jun 23, 1989K893140DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET
Casco Standards
JJX
Jun 9, 1989K885282ASSAYED CHOLINESTERASE CONTROL
Actio, Inc.
JJX
May 22, 1989K892656DRI-DYE CHECK STRIPS (TM)-405
Awareness Technology, Inc.
JJX
Oct 3, 1988K883741QTEST PREGNANCY TEST CONTROL
Quidel Corp.
JJX
Sep 22, 1988K883316QUIDEL PREGNANCY TEST CONTROL
Quidel Corp.
JJX
Jul 8, 1988K881430LIQUI-SERA SERUM ALCOHOL CONTROLS
Biodiagnostic Intl
JJX
Feb 24, 1988K880039AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665
Sigma Diagnostics, Inc.
JJX
Oct 20, 1987K873342BILE ACIDS CONTROLS
Sigma Diagnostics, Inc.
JJX
Sep 21, 1987K873450TRI-LEVEL LIGAND CONTROL
Ciba Corning Diagnostics Corp.
JJX
Sep 16, 1987K873105REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL
Streck Laboratories, Inc.
JJX
Mar 12, 1987K870151TOTAL/IGE THEOPHYLLINE CONTROL SERA
3M Company
JJX
Nov 5, 1986K863744HCG CONTROL KIT
Monoclonal Antibodies, Inc.
JJX
Sep 15, 1986K863126TESTPACK ACUTE HCG SERUM CONTROLS
Abbott Laboratories
JJX
Apr 24, 1986K861221EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
Em Diagnostic Systems, Inc.
JJX
Feb 19, 1986K860453ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
Sigma Diagnostics, Inc.
JJX
Jan 17, 1986K855225ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
Boehringer Mannheim Corp.
JJX
Sep 16, 1985K853553DIASCAN CONTROL
Home Diagnostics, Inc.
JJX
Apr 29, 1985K851043SUGAR-CHEX II
Streck Laboratories, Inc.
JJX

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