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 |
|---|---|---|---|
| Nov 13, 2002 | K022769 | LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION Bionostics, Inc. | JJX |
| Oct 31, 2002 | K023307 | MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL Medical Analysis Systems, Inc. | JJX |
| Sep 23, 2002 | K022725 | CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 Good Biotech Corp., TW | JJX |
| Sep 17, 2002 | K022758 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER Cliniqa Corporation | JJX |
| Aug 27, 2002 | K022491 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS Cliniqa Corporation | JJX |
| Aug 1, 2002 | K022232 | CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 Cliniqa Corporation | JJX |
| Jul 12, 2002 | K021697 | GLUCOSE CONTROL SOLUTION FOR BD LATITUDE Bionostics, Inc. | JJX |
| Jul 12, 2002 | K021624 | RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 Bionostics, Inc. | JJX |
| Mar 15, 2002 | K020217 | ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY Bayer Diagnostics Corp. | JJX |
| Mar 6, 2002 | K020369 | ELECSYS ANTI-TG CALCHECK Roche Diagnostics Corp. | JJX |
| Dec 21, 2001 | K013900 | VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS Ortho-Clinical Diagnostics | JJX |
| Nov 16, 2001 | K013119 | VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 Maine Standards Co. | JJX |
| Oct 24, 2001 | K013147 | GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE Bionostics, Inc. | JJX |
| Oct 18, 2001 | K013130 | N LP(A) CONTROL SY Dade Behring, Inc. | JJX |
| Aug 29, 2001 | K012561 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS Ortho-Clinical Diagnostics | JJX |
| Aug 27, 2001 | K012430 | MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 Bionostics, Inc. | JJX |
| Aug 20, 2001 | K012122 | VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 Maine Standards Co. | JJX |
| Jun 13, 2001 | K011463 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS Ortho-Clinical Diagnostics | JJX |
| Jun 13, 2001 | K011250 | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS Ortho-Clinical Diagnostics, Inc. | JJX |
| Apr 11, 2001 | K010693 | VIGIL DNASE B CONTROL Beckman Coulter, Inc. | JJX |
| Mar 13, 2001 | K010428 | ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 Beckman Coulter, Inc. | JJX |
| Feb 14, 2001 | K010237 | ELECSYS HCG+B CALCHECK Roche Diagnostics Corp. | JJX |
| Jan 12, 2001 | K003967 | CA 125 II CALCHECK Roche Diagnostics Corp. | JJX |
| Dec 20, 2000 | K003772 | ELECSYS DHEA-S CALCHECK Roche Diagnostics Corp. | JJX |
| Nov 29, 2000 | K003095 | FASTPACK CONTROL Qualigen, Inc. | JJX |
| Nov 22, 2000 | K001651 | BIO-RAD %CDT TIA Axis-Shield Biochemicals, Asa | JJX |
| Nov 2, 2000 | K003112 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS Ortho-Clinical Diagnostics, Inc. | JJX |
| Sep 18, 2000 | K002540 | BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS Bionostics, Inc. | JJX |
| Jun 29, 2000 | K001443 | SUGAR CHEX ONE Streck Laboratories, Inc. | JJX |
| Jun 28, 2000 | K001846 | ELECSYS INSULIN CALCHECK Roche Diagnostics Corp. | JJX |
| Jun 2, 2000 | K001458 | SYNCHRON CONTROL Beckman Coulter, Inc. | JJX |
| Jun 1, 2000 | K001014 | ELECSYS ANTI-TPO CALCHECK Roche Diagnostics Corp. | JJX |
| Apr 27, 2000 | K001015 | ELECSYS THYROGLOBULIN CALCHECK Roche Diagnostics Corp. | JJX |
| Apr 5, 2000 | K992781 | ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 Bio-Rad | JJX |
| Mar 17, 2000 | K000042 | ELECSYS B-CROSSLAPS CALCHECK Roche Diagnostics Corp. | JJX |
| Mar 2, 2000 | K000231 | TRIAGE BNP CALIBRATION VERIFICATION CONTROLS Biosite Incorporated | JJX |
| Feb 29, 2000 | K000230 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS Biosite Incorporated | JJX |
| Feb 28, 2000 | K000318 | BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM Bionostics, Inc. | JJX |
| Feb 24, 2000 | K000056 | BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS Biocell Laboratories, Inc. | JJX |
| Jan 18, 2000 | K994200 | ACCESS HYBRITECH PSA QC, MODEL 37209 Beckman Coulter, Inc. | JJX |
| Jan 14, 2000 | K994277 | ACCESS OSTASE QC Beckman Coulter, Inc. | JJX |
| Jan 5, 2000 | K993210 | ACCESS HYBRITECH FREE PSA QC, MODEL 37219 Beckman Coulter, Inc. | JJX |
| Nov 30, 1999 | K993642 | ELECSYS PARATHYROID HORMONE CALCHECK Roche Diagnostics Corp. | JJX |
| Nov 26, 1999 | K981914 | TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION The Binding Site, Ltd. | JJX |
| May 10, 1999 | K991075 | ATLAST GLUCOSE CONTROL SOLUTION Amira Medical, Inc. | JJX |
| Apr 8, 1999 | K990984 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. | JJX |
| Mar 30, 1999 | K990608 | ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 Bio-Rad | JJX |
| Mar 25, 1999 | K990783 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. | JJX |
| Mar 22, 1999 | K990393 | ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 Bio-Rad | JJX |
| Mar 19, 1999 | K990755 | SAS HCG URINE CONTROLS Sa Scientific, Inc. | JJX |
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