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 |
|---|---|---|---|
| Mar 19, 1999 | K990720 | SAS HCG SERUM CONTROLS Sa Scientific, Inc. | JJX |
| Feb 2, 1999 | K984625 | ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 Bio-Rad | JJX |
| Feb 2, 1999 | K984604 | ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 Bio-Rad | JJX |
| Jan 29, 1999 | K990026 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. | JJX |
| Jan 29, 1999 | K984626 | ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 Bio-Rad | JJX |
| Jan 28, 1999 | K990162 | ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 Bio-Rad | JJX |
| Jan 25, 1999 | K990061 | VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. | JJX |
| Dec 22, 1998 | K984327 | ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 Bio-Rad | JJX |
| Dec 22, 1998 | K984319 | ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 Bio-Rad | JJX |
| Dec 17, 1998 | K983432 | SUPREME II CONTROL SOLUTIONS Chronimed, Inc. | JJX |
| Dec 15, 1998 | K984324 | ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 Bio-Rad | JJX |
| Dec 15, 1998 | K984323 | ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 Bio-Rad | JJX |
| Dec 15, 1998 | K984318 | ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 Bio-Rad | JJX |
| Dec 7, 1998 | K984011 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. | JJX |
| Dec 3, 1998 | K984071 | LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 Bio-Rad | JJX |
| Nov 25, 1998 | K984073 | ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 Bio-Rad | JJX |
| Nov 25, 1998 | K984070 | ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 Bio-Rad | JJX |
| Nov 24, 1998 | K984072 | ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 Bio-Rad | JJX |
| Nov 18, 1998 | K983971 | CARDIAC MARKER CONTROL MODULE, MODEL CCCM Diagnostic Products Corp. | JJX |
| Nov 12, 1998 | K983578 | ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 Bio-Rad | JJX |
| Aug 6, 1998 | K982471 | B2-MICROGLOBULIN CONTROL SET SERUM Boehringer Mannheim Corp. | JJX |
| Aug 5, 1998 | K982591 | DADE TRU-LIQUID CARDIAC CONTROL Dade Behring, Inc. | JJX |
| Jul 6, 1998 | K982022 | VIGIL HEMOGLOBIN (HBALC) CONTROLS Beckman Coulter, Inc. | JJX |
| Jun 12, 1998 | K981864 | ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 Beckman Coulter, Inc. | JJX |
| Jun 8, 1998 | K981622 | DADE TRU-LIQUID CARDIAC CONTROL Dade Behring, Inc. | JJX |
| Apr 24, 1998 | K981281 | ELECSYS CALCHECK FERRITIN Roche Diagnostics GmbH | JJX |
| Apr 23, 1998 | K981278 | ELECSYS CALCHECK CA 125II Roche Diagnostics GmbH | JJX |
| Feb 10, 1998 | K974811 | ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL Boston Biomedica, Inc. | JJX |
| Jan 13, 1998 | K974644 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS Johnson & Johnson Clinical Diagnostics, Inc. | JJX |
| Jan 6, 1998 | K974609 | REP CHOLESTEROL PROFILE CONTROL-II Helena Laboratories | JJX |
| Dec 16, 1997 | K973676 | PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH Sorrento Biochemical, Inc. | JJX |
| Dec 15, 1997 | K973678 | ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH Sorrento Biochemical, Inc. | JJX |
| Dec 15, 1997 | K973677 | DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH Sorrento Biochemical, Inc. | JJX |
| Dec 8, 1997 | K974383 | ELECSYS CALCHECK VITAMIN B12 Boehringer Mannheim Corp. | JJX |
| Nov 26, 1997 | K974108 | SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) Quidel Corp. | JJX |
| Oct 27, 1997 | K973832 | OPUS HLH CONTROLS Behring Diagnostics, Inc. | JJX |
| Oct 6, 1997 | K973358 | MYOGLOBIN CONTROL SET Boehringer Mannheim Corp. | JJX |
| Sep 29, 1997 | K973099 | PROSTATE SPECIFIC ANTIGEN CONTROL Dade Chemistry Systems, Inc. | JJX |
| Sep 12, 1997 | K973072 | WAKO NEFA LINEARITY SET Wako Chemicals USA, Inc. | JJX |
| Aug 6, 1997 | K972721 | ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P Roche Diagnostic Systems, Inc. | JJX |
| Jul 28, 1997 | K972687 | CARDIAC STATUS CONTROLS/TROPONIN I Spectral Diagnostics, Inc., CA | JJX |
| Jul 7, 1997 | K972287 | DADE TRU-LIQUID BILIRUBIN CONTROL Dade Intl., Inc. | JJX |
| Apr 23, 1997 | K971014 | LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS Lifescan, Inc. | JJX |
| Apr 17, 1997 | K970778 | LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 More Diagnostics | JJX |
| Apr 10, 1997 | K971051 | IMMULITE THYROID AUTOANTIBODY CONTROL MODULE Diagnostic Products Corp. | JJX |
| Apr 2, 1997 | K970984 | THE ELECSYS CALCHECK PROGESTERONE Boehringer Mannheim Corp. | JJX |
| Mar 6, 1997 | K970459 | ELECSYS CALCHECK CEA Boehringer Mannheim Corp. | JJX |
| Mar 6, 1997 | K970458 | ELECSYS CALCHECK PSA Boehringer Mannheim Corp. | JJX |
| Mar 6, 1997 | K970452 | ELECSYS CALCHECK CEA Boehringer Mannheim Corp. | JJX |
| Mar 3, 1997 | K970527 | ABBOTT HCG SERUM CONTROLS Abbott Laboratories | JJX |
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