| LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION (K022769) | Bionostics, Inc. | 2002-11-13 |
| MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL (K023307) | Medical Analysis Systems, Inc. | 2002-10-31 |
| CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 (K022725) | Good Biotech Corp. | 2002-09-23 |
| LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER (K022758) | Cliniqa Corporation | 2002-09-17 |
| LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K022491) | Cliniqa Corporation | 2002-08-27 |
| CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 (K022232) | Cliniqa Corporation | 2002-08-01 |
| GLUCOSE CONTROL SOLUTION FOR BD LATITUDE (K021697) | Bionostics, Inc. | 2002-07-12 |
| RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 (K021624) | Bionostics, Inc. | 2002-07-12 |
| ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY (K020217) | Bayer Diagnostics Corp. | 2002-03-15 |
| ELECSYS ANTI-TG CALCHECK (K020369) | Roche Diagnostics Corp. | 2002-03-06 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS (K013900) | Ortho-Clinical Diagnostics | 2001-12-21 |
| VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 (K013119) | Maine Standards Co. | 2001-11-16 |
| GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE (K013147) | Bionostics, Inc. | 2001-10-24 |
| N LP(A) CONTROL SY (K013130) | Dade Behring, Inc. | 2001-10-18 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS (K012561) | Ortho-Clinical Diagnostics | 2001-08-29 |
| MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 (K012430) | Bionostics, Inc. | 2001-08-27 |
| VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 (K012122) | Maine Standards Co. | 2001-08-20 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS (K011463) | Ortho-Clinical Diagnostics | 2001-06-13 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K011250) | Ortho-Clinical Diagnostics, Inc. | 2001-06-13 |
| VIGIL DNASE B CONTROL (K010693) | Beckman Coulter, Inc. | 2001-04-11 |
| ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 (K010428) | Beckman Coulter, Inc. | 2001-03-13 |
| ELECSYS HCG+B CALCHECK (K010237) | Roche Diagnostics Corp. | 2001-02-14 |
| CA 125 II CALCHECK (K003967) | Roche Diagnostics Corp. | 2001-01-12 |
| ELECSYS DHEA-S CALCHECK (K003772) | Roche Diagnostics Corp. | 2000-12-20 |
| FASTPACK CONTROL (K003095) | Qualigen, Inc. | 2000-11-29 |
| BIO-RAD %CDT TIA (K001651) | Axis-Shield Biochemicals, Asa | 2000-11-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS (K003112) | Ortho-Clinical Diagnostics, Inc. | 2000-11-02 |
| BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS (K002540) | Bionostics, Inc. | 2000-09-18 |
| SUGAR CHEX ONE (K001443) | Streck Laboratories, Inc. | 2000-06-29 |
| ELECSYS INSULIN CALCHECK (K001846) | Roche Diagnostics Corp. | 2000-06-28 |
| SYNCHRON CONTROL (K001458) | Beckman Coulter, Inc. | 2000-06-02 |
| ELECSYS ANTI-TPO CALCHECK (K001014) | Roche Diagnostics Corp. | 2000-06-01 |
| ELECSYS THYROGLOBULIN CALCHECK (K001015) | Roche Diagnostics Corp. | 2000-04-27 |
| ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 (K992781) | Bio-Rad | 2000-04-05 |
| ELECSYS B-CROSSLAPS CALCHECK (K000042) | Roche Diagnostics Corp. | 2000-03-17 |
| TRIAGE BNP CALIBRATION VERIFICATION CONTROLS (K000231) | Biosite Incorporated | 2000-03-02 |
| TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS (K000230) | Biosite Incorporated | 2000-02-29 |
| BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (K000318) | Bionostics, Inc. | 2000-02-28 |
| BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS (K000056) | Biocell Laboratories, Inc. | 2000-02-24 |
| ACCESS HYBRITECH PSA QC, MODEL 37209 (K994200) | Beckman Coulter, Inc. | 2000-01-18 |
| ACCESS OSTASE QC (K994277) | Beckman Coulter, Inc. | 2000-01-14 |
| ACCESS HYBRITECH FREE PSA QC, MODEL 37219 (K993210) | Beckman Coulter, Inc. | 2000-01-05 |
| ELECSYS PARATHYROID HORMONE CALCHECK (K993642) | Roche Diagnostics Corp. | 1999-11-30 |
| TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION (K981914) | The Binding Site, Ltd. | 1999-11-26 |
| ATLAST GLUCOSE CONTROL SOLUTION (K991075) | Amira Medical, Inc. | 1999-05-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS (K990984) | Ortho-Clinical Diagnostics, Inc. | 1999-04-08 |
| ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 (K990608) | Bio-Rad | 1999-03-30 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS (K990783) | Ortho-Clinical Diagnostics, Inc. | 1999-03-25 |
| ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 (K990393) | Bio-Rad | 1999-03-22 |
| SAS HCG SERUM CONTROLS (K990720) | Sa Scientific, Inc. | 1999-03-19 |
| SAS HCG URINE CONTROLS (K990755) | Sa Scientific, Inc. | 1999-03-19 |
| ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 (K984625) | Bio-Rad | 1999-02-02 |
| ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 (K984604) | Bio-Rad | 1999-02-02 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS (K990026) | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 |
| ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 (K984626) | Bio-Rad | 1999-01-29 |
| ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 (K990162) | Bio-Rad | 1999-01-28 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS (K990061) | Ortho-Clinical Diagnostics, Inc. | 1999-01-25 |
| ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 (K984319) | Bio-Rad | 1998-12-22 |
| ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 (K984327) | Bio-Rad | 1998-12-22 |
| SUPREME II CONTROL SOLUTIONS (K983432) | Chronimed, Inc. | 1998-12-17 |
| ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 (K984318) | Bio-Rad | 1998-12-15 |
| ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 (K984324) | Bio-Rad | 1998-12-15 |
| ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 (K984323) | Bio-Rad | 1998-12-15 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS (K984011) | Ortho-Clinical Diagnostics, Inc. | 1998-12-07 |
| LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 (K984071) | Bio-Rad | 1998-12-03 |
| ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 (K984070) | Bio-Rad | 1998-11-25 |
| ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 (K984073) | Bio-Rad | 1998-11-25 |
| ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 (K984072) | Bio-Rad | 1998-11-24 |
| CARDIAC MARKER CONTROL MODULE, MODEL CCCM (K983971) | Diagnostic Products Corp. | 1998-11-18 |
| ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 (K983578) | Bio-Rad | 1998-11-12 |
| B2-MICROGLOBULIN CONTROL SET SERUM (K982471) | Boehringer Mannheim Corp. | 1998-08-06 |
| DADE TRU-LIQUID CARDIAC CONTROL (K982591) | Dade Behring, Inc. | 1998-08-05 |
| VIGIL HEMOGLOBIN (HBALC) CONTROLS (K982022) | Beckman Coulter, Inc. | 1998-07-06 |
| ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 (K981864) | Beckman Coulter, Inc. | 1998-06-12 |
| DADE TRU-LIQUID CARDIAC CONTROL (K981622) | Dade Behring, Inc. | 1998-06-08 |
| ELECSYS CALCHECK FERRITIN (K981281) | Roche Diagnostics GmbH | 1998-04-24 |
| ELECSYS CALCHECK CA 125II (K981278) | Roche Diagnostics GmbH | 1998-04-23 |
| ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL (K974811) | Boston Biomedica, Inc. | 1998-02-10 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K974644) | Johnson & Johnson Clinical Diagnostics, Inc. | 1998-01-13 |
| REP CHOLESTEROL PROFILE CONTROL-II (K974609) | Helena Laboratories | 1998-01-06 |
| PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH (K973676) | Sorrento Biochemical, Inc. | 1997-12-16 |
| ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH (K973678) | Sorrento Biochemical, Inc. | 1997-12-15 |
| DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH (K973677) | Sorrento Biochemical, Inc. | 1997-12-15 |
| ELECSYS CALCHECK VITAMIN B12 (K974383) | Boehringer Mannheim Corp. | 1997-12-08 |
| SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) (K974108) | Quidel Corp. | 1997-11-26 |
| OPUS HLH CONTROLS (K973832) | Behring Diagnostics, Inc. | 1997-10-27 |
| MYOGLOBIN CONTROL SET (K973358) | Boehringer Mannheim Corp. | 1997-10-06 |
| PROSTATE SPECIFIC ANTIGEN CONTROL (K973099) | Dade Chemistry Systems, Inc. | 1997-09-29 |
| WAKO NEFA LINEARITY SET (K973072) | Wako Chemicals USA, Inc. | 1997-09-12 |
| ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P (K972721) | Roche Diagnostic Systems, Inc. | 1997-08-06 |
| CARDIAC STATUS CONTROLS/TROPONIN I (K972687) | Spectral Diagnostics, Inc. | 1997-07-28 |
| DADE TRU-LIQUID BILIRUBIN CONTROL (K972287) | Dade Intl., Inc. | 1997-07-07 |
| LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS (K971014) | Lifescan, Inc. | 1997-04-23 |
| LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 (K970778) | More Diagnostics | 1997-04-17 |
| IMMULITE THYROID AUTOANTIBODY CONTROL MODULE (K971051) | Diagnostic Products Corp. | 1997-04-10 |
| THE ELECSYS CALCHECK PROGESTERONE (K970984) | Boehringer Mannheim Corp. | 1997-04-02 |
| ELECSYS CALCHECK CEA (K970459) | Boehringer Mannheim Corp. | 1997-03-06 |
| ELECSYS CALCHECK CEA (K970452) | Boehringer Mannheim Corp. | 1997-03-06 |
| ELECSYS CALCHECK PSA (K970458) | Boehringer Mannheim Corp. | 1997-03-06 |
| ABBOTT HCG SERUM CONTROLS (K970527) | Abbott Laboratories | 1997-03-03 |