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)
Top companies in JJX
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostics | 60 | 0 |
| Siemens Healthcare Diagnostics | 34 | 6 |
| Boehringer Mannheim Corp. | 24 | 0 |
| Bionostics, Inc. | 22 | 0 |
| Bio-Rad | 21 | 0 |
| Ortho-Clinical Diagnostics | 13 | 3 |
| Abbott Laboratories | 4 | 9 |
| Beckman Coulter, Inc. | 9 | 4 |
| Casco Standards | 10 | 0 |
| Tosoh Medics, Inc. | 10 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2006 | K062501 | VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 Maine Standards Co. | JJX |
| Jun 19, 2006 | K060510 | DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT Drew Scientific , Ltd., GB | JJX |
| Apr 28, 2006 | K060706 | LIBERTY NORMAL GLUCOSE CONTROL SOLUTION Liberty Healthcare Group, Inc. | JJX |
| Apr 13, 2006 | K060570 | HEMOGLOBIN ALC CONTROL Compass Bioscience | JJX |
| Mar 24, 2006 | K060215 | ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 Eurotrol B.V. | JJX |
| Mar 9, 2006 | K060481 | LIBERTY GLUCOSE CONTROL SOLUTION Liberty Healthcare Group, Inc. | JJX |
| Mar 9, 2006 | K060426 | LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041 Liberty Healthcare Group, Inc. | JJX |
| Feb 16, 2006 | K060133 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET Inverness Medical Innovations, Inc. | JJX |
| Jan 26, 2006 | K060027 | ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) Biokit, S.A., ES | JJX |
| Jan 26, 2006 | K053327 | OXICOM CONTROL Bionostics, Inc. | JJX |
| Nov 30, 2005 | K052980 | LIBERTY GLUCOSE CONTROL, MODEL 2120031 Liberty Healthcare Group, Inc. | JJX |
| Nov 28, 2005 | K053059 | ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK Roche Diagnostics | JJX |
| Nov 18, 2005 | K052679 | CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E Cliniqa Corporation | JJX |
| Oct 4, 2005 | K052010 | HBA1C LINEARITY SET Cone Bioproducts | JJX |
| May 16, 2005 | K050983 | IRMA TRUPOINT CREATININE CONTROL KIT International Technidyne Corporation | JJX |
| May 13, 2005 | K050961 | RNA1C CONTROL FOR NYCOCARD HBA1C Bionostics, Inc. | JJX |
| Mar 29, 2005 | K050328 | PREGNANCY-SKREEN Biochemical Diagnostic, Inc. | JJX |
| Feb 25, 2005 | K050100 | RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER Bionostics, Inc. | JJX |
| Feb 8, 2005 | K043584 | LIQUICHEK BNP CONTROL Bio-Rad Laboratories, Inc. | JJX |
| Dec 17, 2004 | K043320 | MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II Roche Diagnostics Corp. | JJX |
| Dec 9, 2004 | K043070 | LIQUID STABLE HBA1C CONTROL Canterbury Scientific , Ltd., NZ | JJX |
| Nov 5, 2004 | K042717 | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL Medical Analysis Systems, Inc. | JJX |
| Nov 2, 2004 | K042837 | LIQUICHEK ELEVATED CRP CONTROL Bio-Rad | JJX |
| Oct 29, 2004 | K042448 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT General Atomics | JJX |
| Sep 27, 2004 | K042303 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS Ortho-Clinical Diagnostics | JJX |
| Aug 19, 2004 | K042080 | TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM Home Diagnostics, Inc. | JJX |
| Aug 18, 2004 | K041687 | ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR Abbott Laboratories | JJX |
| Aug 16, 2004 | K041898 | CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM Cliniqa Corporation | JJX |
| Aug 16, 2004 | K041871 | INTERLAB MICROCAL SERUM CONTROLS Trouble Shooter Consuling, Inc., IT | JJX |
| Aug 16, 2004 | K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H Medical Analysis Systems, Inc. | JJX |
| May 17, 2004 | K040927 | LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS Cliniqa Corporation | JJX |
| May 17, 2004 | K040918 | WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2 Wako Chemicals USA, Inc. | JJX |
| May 7, 2004 | K041016 | NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS Nova Biomedical Corp. | JJX |
| Mar 12, 2004 | K040351 | RANDOX LIQUID CRP CONTROLS Randox Laboratories, Ltd., GB | JJX |
| Mar 10, 2004 | K034048 | R&D GLU-LINE HEMATOLOGY CONTROL R&D Systems, Inc. | JJX |
| Mar 5, 2004 | K040455 | LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation | JJX |
| Mar 2, 2004 | K040025 | A1C-CELLULAR Streck Laboratories, Inc. | JJX |
| Feb 25, 2004 | K040157 | ELECSYS C-PEPTIDE CALCHECK Roche Diagnostics Corp. | JJX |
| Feb 2, 2004 | K030849 | AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 N-Dia, Inc. | JJX |
| Jan 2, 2004 | K033433 | NOVA GLUCOSE CONTROL SOLUTIONS Nova Biomedical Corp. | JJX |
| Oct 31, 2003 | K033127 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS Ortho-Clinical Diagnostics | JJX |
| Oct 31, 2003 | K032993 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS Ortho-Clinical Diagnostics, Inc. | JJX |
| Oct 20, 2003 | K032819 | GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM Bionostics, Inc. | JJX |
| Oct 7, 2003 | K031873 | I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET I-Stat Corporation | JJX |
| Aug 20, 2003 | K031990 | ELECSYS PRECICONTROL TROPONIN T Roche Diagnostics Corp. | JJX |
| Aug 20, 2003 | K031698 | ELECYS SHBG CALCHECK Roche Diagnostics Corp. | JJX |
| Jul 16, 2003 | K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL Medical Analysis Systems, Inc. | JJX |
| Mar 17, 2003 | K030628 | SAS RSV CONTROL KIT Sa Scientific, Inc. | JJX |
| Feb 11, 2003 | K030065 | WAKO NEFA LINEARITY SET Wako Chemicals USA, Inc. | JJX |
| Nov 29, 2002 | K020883 | ELECSYS PROBNP CALCHECK Roche Diagnostics Corp. | JJX |
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