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 |
|---|---|---|---|
| Jul 18, 2013 | K131776 | ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 Randox Laboratories, Ltd., GB | JJX |
| Jun 14, 2013 | K123127 | VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 Maine Standards Co. | JJX |
| May 31, 2013 | K131136 | GLUCOSE METER-CHECK SOLUTION FOR TAIDOC Bionostics, Inc. | JJX |
| Apr 26, 2013 | K130764 | AUDIT MICROCV VITAMIN D LINEARITY SET Aalto Scientific, Ltd. | JJX |
| Mar 19, 2013 | K130157 | AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET Aalto Scientific, Ltd. | JJX |
| Mar 14, 2013 | K122534 | IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics, Inc. | JJX |
| Feb 14, 2013 | K123851 | GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK Bionostics, Inc. | JJX |
| Jan 25, 2013 | K123966 | GLUCOSE METER-CHECK SOLUTION FOR BAYER Bionostics, Inc. | JJX |
| Jan 17, 2013 | K123612 | FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA Fujirebio Diagnostics,Inc. | JJX |
| Jan 9, 2013 | K123798 | LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK Bio-Rad Laboratories | JJX |
| Dec 5, 2012 | K122242 | ELECSYS CA 15-3 II CALCHECK 5 Roche Diagnostics | JJX |
| Aug 24, 2012 | K121895 | ELECSYS HSV-2 IGG IMMUNOASSAY Roche Diagnostics | JJX |
| Aug 7, 2012 | K122141 | IDS-ISYS IGF-I CALIBRATION VERIFIERS Immunodiagnostic Systems , Ltd., GB | JJX |
| Jul 11, 2012 | K121746 | RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID) Randox Laboratories, Ltd., GB | JJX |
| Jun 20, 2012 | K121588 | RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 Randox Laboratories, Ltd., GB | JJX |
| Jun 20, 2012 | K121534 | CONE-TROL HEMOGLOBIN A1C CONTROL SET Cone Bioproducts | JJX |
| May 18, 2012 | K121237 | BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE Cliniqa Corporation | JJX |
| May 10, 2012 | K121279 | ELECSYS LH CALCHECK 5 Roche Diagnostics | JJX |
| May 10, 2012 | K113177 | COMPLETE D 25-OH VITAMIN D CONTROL Quantimetrix Corp. | JJX |
| May 9, 2012 | K121084 | LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L Siemens Healthcare Diagnostics, Inc. | JJX |
| Apr 9, 2012 | K112653 | ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS ACON Laboratories, Inc. | JJX |
| Feb 14, 2012 | K111938 | IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... Immunodiagnostic Systems , Ltd., GB | JJX |
| Jan 31, 2012 | K112143 | AUDIT MICROCV T-UPTAKE LINEARITY Aalto Scientific, Ltd. | JJX |
| Jan 30, 2012 | K113764 | GLUCOSE METER-CHECK SOLUTION FOR INFOPIA Bionostics, Inc. | JJX |
| Jan 27, 2012 | K113524 | VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT Maine Standards Co. | JJX |
| Dec 23, 2011 | K112352 | GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT Bionostics, Inc. | JJX |
| Nov 4, 2011 | K112603 | ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc. | JJX |
| Oct 18, 2011 | K112528 | ELECSYS T4 CALCHECK 5 Roche Diagnostics Corporation | JJX |
| Sep 21, 2011 | K110061 | CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics | JJX |
| Sep 19, 2011 | K112356 | GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE Bionostics, Inc. | JJX |
| Sep 14, 2011 | K112113 | ELECSYS MYOGLOBIN CALCHECK 5 Roche Diagnostics | JJX |
| Sep 6, 2011 | K111650 | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... Immunodiagnostic Systems , Ltd., GB | JJX |
| Aug 25, 2011 | K112104 | ELECSYS N-MID OSTEOCALCIN CALCHECK 5 Roche Diagnostics | JJX |
| Jul 21, 2011 | K111552 | ELECSYS T3 CALCHECK 5 Roche Diagnostics | JJX |
| Jun 9, 2011 | K111349 | ELECSYS SHBG CALCHECK 5 Roche Diagnostics | JJX |
| May 27, 2011 | K110641 | FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL Fujirebio Diagnostics,Inc. | JJX |
| May 12, 2011 | K110613 | ELECSYS PROLACTIN II CALCHECK 5 Roche Diagnostics | JJX |
| May 12, 2011 | K103744 | DROPPER A1C DIABETES CONTROL Quantimetrix Corp. | JJX |
| Apr 28, 2011 | K103683 | IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) Siemens Healthcare Diagnostics | JJX |
| Apr 20, 2011 | K110436 | FDI GLUCOSE CONTROL SOLUTION FOR AVIVA Fujirebio Diagnostics,Inc. | JJX |
| Mar 16, 2011 | K110412 | IDS-ISYS IFG-I CONTROL SET Immunodiagnostic Systems , Ltd., GB | JJX |
| Feb 10, 2011 | K103553 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION Bionostics, Inc. | JJX |
| Jan 25, 2011 | K103450 | FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE Fujirebio Diagnostics,Inc. | JJX |
| Jan 7, 2011 | K103402 | ELECSYS DHEA-S CALCHECK 5 Roche Diagnostics | JJX |
| Dec 23, 2010 | K101427 | AUDIT MICROCV HS-CRP LINEARITY SET Aalto Scientific, Ltd. | JJX |
| Dec 23, 2010 | K100715 | AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 Aalto Scientific, Ltd. | JJX |
| Dec 6, 2010 | K103099 | PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH Roche Diagnostics | JJX |
| Nov 23, 2010 | K102904 | ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL Siemens Healthcare Diagnostics | JJX |
| Nov 18, 2010 | K103162 | ELECSYS PTH CALCHECK 5 Roche Diagnostics | JJX |
| Nov 1, 2010 | K102086 | ELECSYS CA 125 II CALCHECK 5 Roche Diagnostics | JJX |
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