| ELECSYS CALCHECK ESTRADIOL (K970148) | Boehringer Mannheim Corp. | 1997-02-10 |
| HCG CONTROLS (K970176) | International Newtech Development, Inc. | 1997-02-06 |
| ELECSYS CALCHECK TESTOSTERONE (K970146) | Boehringer Mannheim Corp. | 1997-01-30 |
| ELECSYS CALCHECK LH (K964830) | Boehringer Mannheim Corp. | 1996-12-16 |
| WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 (K964278) | Clinical Controls, Inc. | 1996-11-22 |
| HEMOCUE GLUCOLIN (K963909) | Direct Solutions | 1996-11-08 |
| HEMOCUE GLUCOTROL (K964053) | Direct Solutions | 1996-11-01 |
| RADIAS GALT TEST (K961432) | Bio-Rad | 1996-10-28 |
| BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 (K963551) | Biocell Laboratories, Inc. | 1996-10-07 |
| ELECSYS CALCHECK T UPDATE (K963181) | Boehringer Mannheim Corp. | 1996-09-10 |
| ELECSYS CALCHECK HCG (K963165) | Boehringer Mannheim Corp. | 1996-08-30 |
| PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) (K962975) | Diagnostic Products Corp. | 1996-08-29 |
| IMMULITE ACTH CONTROL MODULE (LACCM) (K963240) | Diagnostic Products Corp. | 1996-08-29 |
| ELECSYS CALCHECK FT4 (K963164) | Boehringer Mannheim Corp. | 1996-08-27 |
| ELECSYS CALCHECK FT3 (K963163) | Boehringer Mannheim Corp. | 1996-08-27 |
| ELECSYS CALCHECK T4 (K963178) | Boehringer Mannheim Corp. | 1996-08-27 |
| ELECYS CALCHECK T 3 (K963167) | Boehringer Mannheim Corp. | 1996-08-27 |
| ELECSYS CALCHECK TROPONIN T (K963143) | Boehringer Mannheim Corp. | 1996-08-23 |
| ELECSYS CALCHECK CK-MB (K963182) | Boehringer Mannheim Corp. | 1996-08-23 |
| ELECSYS CALCHECK TSH (K963147) | Boehringer Mannheim Corp. | 1996-08-23 |
| LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III (K963085) | International Enzymes, Inc. | 1996-08-20 |
| OPUS MYOGLOBIN CONTROLS (K962841) | Behring Diagnostics, Inc. | 1996-08-15 |
| OPUS B12 CONTROLS (K962694) | Behring Diagnostics, Inc. | 1996-07-22 |
| ELECSYS PRECICONTROL TSH (K962573) | Boehringer Mannheim Corp. | 1996-07-22 |
| LIQUISPEX URINE (MICRO)ALBUMIN CONTROL (K962432) | Clinical Controls, Inc. | 1996-07-05 |
| ACS FRT4 IMMUNOASSAY (K961510) | Ciba Corning Diagnostics Corp. | 1996-06-17 |
| COMPLEMENT CONTROL (K960874) | Wako Chemicals USA, Inc. | 1996-06-14 |
| OPUS T3 CONTROLS (K961206) | Behring Diagnostics, Inc. | 1996-04-23 |
| ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS (K960378) | Actimed Laboratories, Inc. | 1996-04-03 |
| LXN FRUCTOSAMINE TEST (K955629) | Lxn Corp. | 1996-03-20 |
| PSA CONTROLS (K960154) | Diagnostic Products Corp. | 1996-03-13 |
| IRON CALIBRATOR & CALIBRATION VERIFICATION SET (K955796) | Data Medical Associates, Inc. | 1996-02-29 |
| OPUS PROLACTIN CONTROLS (K955468) | Behring Diagnostics, Inc. | 1996-02-23 |
| OSOM HCG COMBO TEST (K955141) | Wyntek Diagnostics, Inc. | 1995-12-06 |
| ACCESS LOW LEVEL IGE CONTROLS (K953883) | Bio-Rad Laboratories, Inc. | 1995-11-14 |
| OPUS HCG CONTROLS (K954144) | Behring Diagnostics, Inc. | 1995-10-06 |
| IMMULITE HCG HIGH LEVEL CONTROL MODULE (K952251) | Diagnostic Products Corp. | 1995-09-08 |
| OPUS T4 CONTROLS (K953097) | Behring Diagnostics, Inc. | 1995-08-24 |
| DADE STRATUS TROPONIN-I CONTROL (K951888) | Dade Intl., Inc. | 1995-07-13 |
| SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 (K944999) | More Diagnostics | 1995-06-06 |
| IMMULITE(R) TBG (K950072) | Diagnostic Products Corp. | 1995-04-03 |
| REP CHOLESTEROL PROFILE CONTROL (K950590) | Helena Laboratories | 1995-03-30 |
| CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL (K950589) | Creative Laboratory Products, Inc. | 1995-03-20 |
| LIQUISPEX(TM) URINE ETHANOL CONTROL (K946144) | Clinical Controls, Inc. | 1995-02-08 |
| CHEMSPEX(TM) AMMONIA CONTROL (K946143) | Clinical Controls, Inc. | 1995-02-03 |
| DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET (K945718) | Casco Standards | 1995-01-17 |
| SAS QUANT HCG SERUM (K944785) | Sa Scientific, Inc. | 1995-01-17 |
| DOCUMENT R AMMONIA/ETHANOL CONTROL (K944361) | Casco Standards | 1994-11-30 |
| QUANTITATE URIC ACID VERIFIER SET (K944453) | Beckman Instruments, Inc. | 1994-11-22 |
| SAS QUANT HCG URINE (K944891) | Sa Scientific, Inc. | 1994-11-17 |
| SERUM PROTEIN CONTROLS (K944515) | Pyramid Biological Corp. | 1994-11-17 |
| DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET (K944338) | Casco Standards | 1994-11-15 |
| TNT TROPONIN T (K942632) | Streck Laboratories, Inc. | 1994-09-09 |
| CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET (K942284) | Creative Laboratory Products, Inc. | 1994-08-26 |
| HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (K941433) | Hichem Diagnostics | 1994-08-02 |
| AXSYM LUTEINIZING HORMONE (LH) (K935611) | Abbott Laboratories | 1994-06-21 |
| GLUCOMETER ELITE LOW CONTROL (K940577) | Heraeus Kulzer, Inc. | 1994-06-13 |
| ASSURE URINE HCG CONTROL (K941130) | Quantimetrix Corp. | 1994-06-03 |
| GLYCATED PROTEIN CONTROLS (K940142) | Primus Corp. | 1994-04-26 |
| ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL (K940272) | Analytical Control Systems, Inc. | 1994-04-20 |
| DOCUMENT(R) ZERO (K940568) | Casco Standards | 1994-04-05 |
| SERUM AMMONIA CONTROL (K935606) | P.T. Meditrol | 1994-03-22 |
| REFRACTOMETRIC, TOTAL PROTEIN (K933218) | Pyramid Biological Corp. | 1994-02-17 |
| P-AMYLASE CONTROL (K935362) | Beckman | 1994-01-27 |
| CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET (K934923) | Unipath , Ltd. | 1993-12-29 |
| CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET (K934922) | Unipath , Ltd. | 1993-12-29 |
| B-HCG HUMAN SERUM CONTROLS (K932479) | Pyramid Biological Corp. | 1993-12-02 |
| SPQ MALB CONTROL LEVEL II (K934521) | Incstar Corp. | 1993-11-26 |
| LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2 (K932660) | More Diagnostics | 1993-10-28 |
| SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES (K933744) | Sa Scientific, Inc. | 1993-09-24 |
| AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES (K932178) | Tosoh Medics, Inc. | 1993-09-21 |
| IMMULITE TSH THIRD GENERATION CONTROL (K930007) | Diagnostic Products Corp. | 1993-08-16 |
| DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET (K932870) | Casco Standards | 1993-08-02 |
| CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3 (K932658) | More Diagnostics | 1993-07-28 |
| MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM (K932659) | More Diagnostics | 1993-07-28 |
| CANNABINOID URINE CONTROLS (K932113) | Diagnostic Reagents, Inc. | 1993-06-29 |
| QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) (K931761) | Quidel Corp. | 1993-06-22 |
| AIA-PACK IGE CALIBRATION VERIFICATION TEST SET (K924859) | Tosoh Medics, Inc. | 1993-05-14 |
| LD-1 CONTROL-LEVEL 1 & 2 (K930874) | Cala Diagnostics | 1993-04-22 |
| AUTOSTAT ANTI-DSDNA (K925783) | Cogent Diagnotics , Ltd. | 1993-03-22 |
| AIA-PACK AFP CALIBRATION VERIFICATION TEST SET (K924860) | Tosoh Medics, Inc. | 1993-03-04 |
| NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL (K925906) | Analytical Control Systems, Inc. | 1993-02-18 |
| TANDEM-E IGE II CALIBRATION VERIFICATION SET (K922754) | Hybritech, Inc. | 1993-02-17 |
| KODAK AMERLITE CK-MB CONTROL SERA LAN.4413 (K925880) | Eastman Kodak Company | 1993-02-05 |
| SUGAR CHEX LINEARITY FOR THE ONE TOUCH (K925479) | Streck Laboratories, Inc. | 1993-01-28 |
| REFRACTROL-SP (K926095) | Medical Specialties, Inc. | 1993-01-26 |
| AIA-PACK PRL CALIBRATION VERIFICATION TEST SET (K924856) | Tosoh Medics, Inc. | 1993-01-11 |
| DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD (K924493) | Casco Standards | 1993-01-11 |
| ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET (K924852) | Tosoh Medics, Inc. | 1993-01-11 |
| AIA-PACK HCG CALIBRATION VERIFICATION TEST SET (K924862) | Tosoh Medics, Inc. | 1992-12-28 |
| CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 (K926015) | Cala Diagnostics | 1992-12-28 |
| AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET (K924853) | Tosoh Medics, Inc. | 1992-12-28 |
| TSH - THIRD GENERATION LOW CONTROLS (K924675) | Nichols Institute | 1992-11-18 |
| AIA-PACK FSH CALIBRATION VERIFICATION TEST SET (K924863) | Tosoh Medics, Inc. | 1992-11-16 |
| AIA-PACK PAP CALIBRATION VERIFICATION TEST SET (K924854) | Tosoh Medics, Inc. | 1992-11-16 |
| AIA-PACK T-U CALIBRATION VERIFICATION TEST SET (K924855) | Tosoh Medics, Inc. | 1992-11-16 |
| DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET (K923821) | Casco Standards | 1992-11-05 |
| DOCUMENT CHEM III CALIBRATION VERIFICATION TEST (K923793) | Casco Standards | 1992-11-05 |
| DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET (K923794) | Casco Standards | 1992-11-05 |
| LIPID CONTROLS (K922995) | Creative Laboratory Products, Inc. | 1992-08-12 |