| ASCENSIA BREEZE BLOOD GLUCOSE METER (K024062) | Bayer Corp. | 2003-03-03 |
| BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST (K023944) | Bayer Corp. | 2003-02-11 |
| BAYER ADVIA CENTAUR HER-2/NEU ASSAY (K024017) | Bayer Corp. | 2003-01-30 |
| ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL (K024234) | Bayer Corp. | 2003-01-23 |
| COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K022288) | Bayer Corp. | 2002-12-17 |
| ASCENSIA DEX 2 DIABETES CARE SYSTEM (K023584) | Bayer Corp. | 2002-11-20 |
| CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM (K020828) | Bayer Corp. | 2002-07-24 |
| CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM (K021428) | Bayer Corp. | 2002-07-05 |
| ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (K020806) | Bayer Corp. | 2002-03-27 |
| CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K013568) | Bayer Corp. | 2001-12-21 |
| BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM (K012337) | Bayer Corp. | 2001-12-06 |
| ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY (K011963) | Bayer Corp. | 2001-11-20 |
| ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY (K013272) | Bayer Corp. | 2001-10-25 |
| ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS (K012777) | Bayer Corp. | 2001-10-22 |
| BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) (K012340) | Bayer Corp. | 2001-10-01 |
| GLUCOMETER DEX TEST SENSOR (K012205) | Bayer Corp. | 2001-09-12 |
| BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY (K010755) | Bayer Corp. | 2001-08-20 |
| BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY (K010668) | Bayer Corp. | 2001-07-05 |
| ADVIA CENTAUR RUBELLA IGG ASSAY (K003412) | Bayer Corp. | 2001-04-13 |
| BAYER ADVIA IMS SYSTEM (K010201) | Bayer Corp. | 2001-03-29 |
| ADVIA 120 HEMATOLOGY (K003796) | Bayer Corp. | 2001-02-05 |
| BAYER RAPIDPOINT 400 SYSTEM (K002738) | Bayer Corp. | 2000-12-19 |
| ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY (K002376) | Bayer Corp. | 2000-10-26 |
| BAYER IMMUNO 1 HER-2/NEU ASSAY (K992228) | Bayer Corp. | 2000-09-29 |
| ADVIA IMS (K001344) | Bayer Corp. | 2000-06-26 |
| ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM (K000903) | Bayer Corp. | 2000-05-18 |
| BAYER ADVIA IMS SYSTEM; 200 + 3 (K000921) | Bayer Corp. | 2000-05-18 |
| BAYER PSA ASSAY (K994221) | Bayer Corp. | 2000-04-13 |
| BAYER ADVIA IMS SYSTEM (K993867) | Bayer Corp. | 2000-04-10 |
| 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (K992662) | Bayer Corp. | 2000-02-15 |
| ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) (K993711) | Bayer Corp. | 1999-12-16 |
| BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 (K993571) | Bayer Corp. | 1999-12-16 |
| TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) (K993353) | Bayer Corp. | 1999-12-06 |
| BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY (K993309) | Bayer Corp. | 1999-12-06 |
| NEW MULTIPLES REAGENT STRIPS (K992257) | Bayer Corp. | 1999-11-24 |
| MICROALBUSTIX REAGENT STRIPS (OTC) (K991315) | Bayer Corp. | 1999-11-12 |
| ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K991907) | Bayer Corp. | 1999-11-09 |
| BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) (K992136) | Bayer Corp. | 1999-11-09 |
| ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K992399) | Bayer Corp. | 1999-09-15 |
| ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (K991817) | Bayer Corp. | 1999-07-22 |
| GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS (K990649) | Bayer Corp. | 1999-07-09 |
| ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM (K991576) | Bayer Corp. | 1999-06-30 |
| GLUCOMETER ELITE TEST STRIPS (K991242) | Bayer Corp. | 1999-06-30 |
| BAYER ADVIA 1650 CHEMISTRY SYSTEM (K990346) | Bayer Corp. | 1999-05-21 |
| THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K983715) | Bayer Corp. | 1999-05-14 |
| GLUCOMETER ELITE XL BLOOD GLUCOSE METER (K984006) | Bayer Corp. | 1999-03-18 |
| BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K982328) | Bayer Corp. | 1999-01-29 |
| BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY (K983345) | Bayer Corp. | 1998-12-07 |
| BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY (K982714) | Bayer Corp. | 1998-10-22 |
| BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K982802) | Bayer Corp. | 1998-09-22 |
| MICROALBUSTIX REAGENT STRIPS (K982219) | Bayer Corp. | 1998-08-12 |
| 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K981312) | Bayer Corp. | 1998-06-05 |
| THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K980376) | Bayer Corp. | 1998-04-23 |
| DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS (K980521) | Bayer Corp. | 1998-04-02 |
| UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K974721) | Bayer Corp. | 1998-03-03 |
| TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K973616) | Bayer Corp. | 1997-12-05 |
| THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964703) | Bayer Corp. | 1997-12-01 |
| CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964098) | Bayer Corp. | 1997-10-31 |
| TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K971989) | Bayer Corp. | 1997-10-22 |
| DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972580) | Bayer Corp. | 1997-09-22 |
| AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972462) | Bayer Corp. | 1997-09-22 |
| CLINITEK MICROALBUMIN REAGENT STRIPS (K972706) | Bayer Corp. | 1997-09-09 |
| ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM (K971998) | Bayer Corp. | 1997-08-29 |
| PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971716) | Bayer Corp. | 1997-06-27 |
| GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER (K971276) | Bayer Corp. | 1997-06-16 |
| N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971713) | Bayer Corp. | 1997-06-11 |
| B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964791) | Bayer Corp. | 1997-05-29 |
| CLINITEK HCG TEST STRIPS (K971209) | Bayer Corp. | 1997-04-04 |
| GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS (K964004) | Bayer Corp. | 1997-02-10 |
| GLUCOMETER ELITE BLOOD GLUCOSE METER (K964630) | Bayer Corp. | 1997-02-10 |
| GLUCOMETER DEX DIABETES CARE SYSTEM (K963500) | Bayer Corp. | 1997-01-21 |
| VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM (K964587) | Bayer Corp. | 1997-01-13 |
| QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964116) | Bayer Corp. | 1996-12-24 |
| VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964442) | Bayer Corp. | 1996-12-18 |
| CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964068) | Bayer Corp. | 1996-12-13 |
| TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K963080) | Bayer Corp. | 1996-09-27 |
| DCA 2000 + MICROALBUMIN/CREATININE ASSAY (K963142) | Bayer Corp. | 1996-09-27 |
| RETICULOCYTE METHOD (K954607) | Bayer Corp. | 1996-08-30 |
| RETICULOCYTE METHOD, RBC INDICES (K954594) | Bayer Corp. | 1996-08-23 |
| MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K962344) | Bayer Corp. | 1996-08-15 |
| TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM (K955760) | Bayer Corp. | 1996-08-02 |
| TECHNICON IMMUNO 1 SYSTEM (K962125) | Bayer Corp. | 1996-08-02 |
| FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K962355) | Bayer Corp. | 1996-07-12 |
| CHEK-STIX U.T.I. SELF-TEST (K960888) | Bayer Corp. | 1996-07-05 |
| CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (K961412) | Bayer Corp. | 1996-06-18 |
| HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K955087) | Bayer Corp. | 1996-06-13 |
| CLINITEK 50 URINE CHEMISTRY ANALYZER (K960546) | Bayer Corp. | 1996-06-12 |
| HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD (K961351) | Bayer Corp. | 1996-06-03 |
| RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE (K951359) | Bayer Corp. | 1996-04-15 |
| RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K954332) | Bayer Corp. | 1996-01-24 |
| QUINTEST (K953939) | Bayer Corp. | 1995-11-13 |
| GLUCOMETER ELITE M BLOOD GLUCOSE METER (K951537) | Bayer Corp. | 1995-07-14 |
| PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (K952075) | Bayer Corp. | 1995-06-13 |
| DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K951631) | Bayer Corp. | 1995-06-09 |
| ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K951360) | Bayer Corp. | 1995-05-02 |
| GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST (K893117) | Bayer Corp. | 1989-06-16 |