| LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (K880605) | Miles Laboratories, Inc. | 1988-05-26 |
| MICRO-BUMINTEST REAGENT TABLETS (K874909) | Miles Laboratories, Inc. | 1988-04-28 |
| MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (K875079) | Miles Laboratories, Inc. | 1988-04-05 |
| GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (K871835) | Miles Laboratories, Inc. | 1987-12-22 |
| SERALYZER III BLOOD CHEMISTRY ANALYZER (K872120) | Miles Laboratories, Inc. | 1987-10-28 |
| CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (K873304) | Miles Laboratories, Inc. | 1987-09-11 |
| CUTTER PUREFLO PLUS IV FILTER (K872634) | Miles Laboratories, Inc. | 1987-08-04 |
| MODIFIED SALTEX REAGENT STRIPS (K870214) | Miles Laboratories, Inc. | 1987-06-29 |
| SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (K870752) | Miles Laboratories, Inc. | 1987-04-14 |
| SERA-TEK MICROSOMAL ANTIBODY TEST (K865053) | Miles Laboratories, Inc. | 1987-02-18 |
| SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (K864530) | Miles Laboratories, Inc. | 1987-02-18 |
| SERA-TEK THYROGLOBULIN ANTIBODY TEST (K865020) | Miles Laboratories, Inc. | 1987-02-02 |
| SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT (K863842) | Miles Laboratories, Inc. | 1987-01-14 |
| GLUCOFACTS DATA MANAGEMENT SYSTEM (K861844) | Miles Laboratories, Inc. | 1986-08-12 |
| GLUCOFACTS DATA PRINTER (K861779) | Miles Laboratories, Inc. | 1986-08-08 |
| GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER (K861303) | Miles Laboratories, Inc. | 1986-07-02 |
| CLINIFACTS 200 DATA MANAGEMENT SYSTEM (K861778) | Miles Laboratories, Inc. | 1986-07-02 |
| GLUCOMETER M BLOOD GULCOSE METER (K855202) | Miles Laboratories, Inc. | 1986-07-02 |
| GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD (K855203) | Miles Laboratories, Inc. | 1986-02-11 |
| SERALYZER TOTAL BILIRUBIN CALIBRATORS (K855040) | Miles Laboratories, Inc. | 1986-01-22 |
| SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT (K852946) | Miles Laboratories, Inc. | 1985-09-30 |
| TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE (K852611) | Miles Laboratories, Inc. | 1985-09-03 |
| GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT (K851703) | Miles Laboratories, Inc. | 1985-08-23 |
| VISIDEX II REAGENT STRIPS (K852747) | Miles Laboratories, Inc. | 1985-08-12 |
| OPTIMATE DIGOXIN TEST (K853021) | Miles Laboratories, Inc. | 1985-08-07 |
| CYTO-TEK CENTRIFUGE (K852117) | Miles Laboratories, Inc. | 1985-06-10 |
| SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & (K844955) | Miles Laboratories, Inc. | 1985-03-19 |
| SERALYZER ARIS PHENYTOIN REAGENT STRIPS (K842092) | Miles Laboratories, Inc. | 1985-03-19 |
| CLINIFACTS 10 DATA MANAGEMENT SYSTEM (K844907) | Miles Laboratories, Inc. | 1985-01-18 |
| LEUKOSTIX REAGENT STRIPS FOR URINALYSIS (K843727) | Miles Laboratories, Inc. | 1985-01-04 |
| TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM (K842470) | Miles Laboratories, Inc. | 1984-08-28 |
| TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG (K842468) | Miles Laboratories, Inc. | 1984-08-28 |
| CLINI-TEK AUTO 2000 REFLECTANCE SPECTR (K841041) | Miles Laboratories, Inc. | 1984-08-24 |
| AMES TDA PHENOBARBITAL TEST (K842592) | Miles Laboratories, Inc. | 1984-08-17 |
| CLINITEK 200 SEMI-AUTOMATED URINALYSIS (K842237) | Miles Laboratories, Inc. | 1984-08-15 |
| CLINITEK 10 SEMI-AUTO URINALYSIS SYS (K842238) | Miles Laboratories, Inc. | 1984-07-25 |
| CITOJECT CARTRIDGE SYRINGE (K842006) | Miles Laboratories, Inc. | 1984-07-16 |
| OPTIMATE IGM TEST (K841814) | Miles Laboratories, Inc. | 1984-06-22 |
| OPTIMATE IGG TEST (K841816) | Miles Laboratories, Inc. | 1984-06-22 |
| OPTIMATE IGA TEST (K841815) | Miles Laboratories, Inc. | 1984-06-01 |
| OPTIMATE DIGOXIN TEST (K841582) | Miles Laboratories, Inc. | 1984-05-11 |
| SERALYZER THEOPHYLLINE REAGENT STRIPS (K832825) | Miles Laboratories, Inc. | 1984-03-19 |
| SERALYZER DRUG ASSAY CONTROL SERUM (K833977) | Miles Laboratories, Inc. | 1984-03-19 |
| AMES TDA NETILMICIN TEST & SERUM (K832088) | Miles Laboratories, Inc. | 1983-10-28 |
| SERAYZER ALT/SGPT REAGENT STRIPS (K832791) | Miles Laboratories, Inc. | 1983-10-14 |
| SERALYZER AST/SGOT REAGENT STRIPS (K832790) | Miles Laboratories, Inc. | 1983-10-14 |
| SERALYZER TRIGLYCERIDES REAGENT STRIPS (K832684) | Miles Laboratories, Inc. | 1983-10-04 |
| AMES TDA DISOPYRAMIDE TEST (K832766) | Miles Laboratories, Inc. | 1983-09-29 |
| AMES TDA SISOMICIN TEST-CONTROL SERUM (K832792) | Miles Laboratories, Inc. | 1983-09-29 |
| AMES TDA KANAMYCIN TEST-CONTROL SERUM (K832769) | Miles Laboratories, Inc. | 1983-09-29 |
| SERA-TEK MYCOPLASMA ANTIBODY TEST (K832132) | Miles Laboratories, Inc. | 1983-09-20 |
| DIASTIX REAGENT STRIPS FOR URINALYSIS (K831600) | Miles Laboratories, Inc. | 1983-09-08 |
| SERALYZER MULTICOMPONENT CALIBRATORS (K832046) | Miles Laboratories, Inc. | 1983-08-11 |
| VISIDEX II REAGENT STRIPS (K831989) | Miles Laboratories, Inc. | 1983-08-08 |
| TISSUE-TEK V.I.P. 100/200 (K831313) | Miles Laboratories, Inc. | 1983-07-28 |
| AMWA TDA THEOPHYLLINE TEST (K831514) | Miles Laboratories, Inc. | 1983-06-30 |
| AMES TDA N-ACETYL-PROCAINAMIDE TEST (K831399) | Miles Laboratories, Inc. | 1983-06-02 |
| AMES TDA PROCAINAMIDE TEST (K831400) | Miles Laboratories, Inc. | 1983-06-02 |
| AZLIN AZLOCILIN SODIUM-DIAG. REAGENT (K830758) | Miles Laboratories, Inc. | 1983-05-25 |
| AMES TDA VALPROIC ACID TEST (K830789) | Miles Laboratories, Inc. | 1983-04-12 |
| AMES TDA ETHOSUXIMIDE TEST (K823801) | Miles Laboratories, Inc. | 1983-01-14 |
| AMES TDA GENTAMICIN TEST (K821669) | Miles Laboratories, Inc. | 1982-12-15 |
| CLINISTAT TDA SERIES (K823112) | Miles Laboratories, Inc. | 1982-11-29 |
| FLUOROSTAT FLUOROMETER (K822701) | Miles Laboratories, Inc. | 1982-10-08 |
| SERALYZER HEMOGLOBIN REAGENT STRIPS (K822044) | Miles Laboratories, Inc. | 1982-07-30 |
| SERALYZER HEMOGLOBIN CALIBRATORS (K822046) | Miles Laboratories, Inc. | 1982-07-30 |
| SERALYZER HEMOGLOBIN TEST MODULE (K822045) | Miles Laboratories, Inc. | 1982-07-30 |
| CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST (K821738) | Miles Laboratories, Inc. | 1982-07-06 |
| ACCUDEX REAGENT STRIPS (K821247) | Miles Laboratories, Inc. | 1982-05-21 |
| VISIDEX REAGENT STRIPS (K821179) | Miles Laboratories, Inc. | 1982-05-14 |
| SERALYZER CK REAGENT STRIPS (K820880) | Miles Laboratories, Inc. | 1982-04-16 |
| SERALYZER CREATININE REAGENT STRIPS (K820075) | Miles Laboratories, Inc. | 1982-01-26 |
| Q-LINE LTC (K813580) | Miles Laboratories, Inc. | 1982-01-18 |
| AMES TDA QUINIDINE TEST (K812753) | Miles Laboratories, Inc. | 1981-10-19 |
| TISSUE-TEK III ACCU-CUT ROTARY MICROTOME (K812558) | Miles Laboratories, Inc. | 1981-09-29 |
| AMES TDA THEOPHYLLINE TEST (K812518) | Miles Laboratories, Inc. | 1981-09-23 |
| REAGENT STRIPS FOR URINALYSIS (K811342) | Miles Laboratories, Inc. | 1981-09-01 |
| SERALYZER (K812100) | Miles Laboratories, Inc. | 1981-08-12 |
| AMES TDA CARBAMAZEPINE TEST (K811952) | Miles Laboratories, Inc. | 1981-07-15 |
| LAB-TEK JEMBEC G.C. CULTURE SYSTEM (K811382) | Miles Laboratories, Inc. | 1981-06-16 |
| AMES SERA-PAK GLUCOSE REAGENT (K811392) | Miles Laboratories, Inc. | 1981-05-29 |
| AMES TDA TM AMIKACIN TEST (K811026) | Miles Laboratories, Inc. | 1981-04-29 |
| AMES TDA TM PRIMIDONE TEST (K811007) | Miles Laboratories, Inc. | 1981-04-29 |
| AMES TDA TM PHENYTOIN TEST (K811025) | Miles Laboratories, Inc. | 1981-04-29 |
| AMES TDA TM PHENOBARBITAL TEST (K810994) | Miles Laboratories, Inc. | 1981-04-29 |
| AMES TDA THEOPHYLLINE TEST (K810943) | Miles Laboratories, Inc. | 1981-04-17 |
| AMES TDA TOBRAMYCIN TEST (K810941) | Miles Laboratories, Inc. | 1981-04-17 |
| AMES TDA GENTAMICIN TEST (K810942) | Miles Laboratories, Inc. | 1981-04-17 |
| SERALYZER SYSTEM (K810639) | Miles Laboratories, Inc. | 1981-03-31 |
| HISTOLOGICAL EMBEDDING MEDIA (K803241) | Miles Laboratories, Inc. | 1981-01-28 |
| AMES SERA-PAK HEMOGLOBIN REAGENT (K803248) | Miles Laboratories, Inc. | 1981-01-26 |
| AMES SERA-PAK ALBUMIN REAGENT KIT (K803237) | Miles Laboratories, Inc. | 1981-01-09 |
| SERALYZER LDH REAGENT STRIPS, CALIBR (K803019) | Miles Laboratories, Inc. | 1980-12-22 |
| AMES TDA AMIKACIN CONTROL SERUM (K803107) | Miles Laboratories, Inc. | 1980-12-22 |
| SERA-PAK TOTAL PROTEIN REAGENT (K802742) | Miles Laboratories, Inc. | 1980-12-11 |
| AMES SERA-PAK URIC ACID REAGENT KIT (K802724) | Miles Laboratories, Inc. | 1980-12-10 |
| AMES SERA-PAK CHOLESTEROL REAGENT KIT (K802743) | Miles Laboratories, Inc. | 1980-12-10 |
| AMES TDA PRIMIDONE TEST (K802654) | Miles Laboratories, Inc. | 1980-11-12 |
| AMES TDA PHENOBARBITAL TEST (K802255) | Miles Laboratories, Inc. | 1980-09-26 |
| TISSUE-TEK III TISSUE EMBEDDING CENTER (K801956) | Miles Laboratories, Inc. | 1980-09-16 |