FDA 510(k) Applications Submitted by JOHN H ENGELMANN

FDA 510(k) Number Submission Date Device Name Applicant
K855040 12/17/1985 SERALYZER TOTAL BILIRUBIN CALIBRATORS MILES LABORATORIES, INC.
K855202 12/26/1985 GLUCOMETER M BLOOD GULCOSE METER MILES LABORATORIES, INC.
K855203 12/26/1985 GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD MILES LABORATORIES, INC.
K870214 01/20/1987 MODIFIED SALTEX REAGENT STRIPS MILES LABORATORIES, INC.
K870752 02/25/1987 SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS MILES LABORATORIES, INC.
K861303 04/07/1986 GLUCOMETER II "IMPROVED" REFLECTANCE PHOTOMETER MILES LABORATORIES, INC.
K861778 05/08/1986 CLINIFACTS 200 DATA MANAGEMENT SYSTEM MILES LABORATORIES, INC.
K861779 05/08/1986 GLUCOFACTS DATA PRINTER MILES LABORATORIES, INC.
K871835 05/11/1987 GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT MILES LABORATORIES, INC.
K861844 05/13/1986 GLUCOFACTS DATA MANAGEMENT SYSTEM MILES LABORATORIES, INC.
K852117 05/15/1985 CYTO-TEK CENTRIFUGE MILES LABORATORIES, INC.
K852611 06/19/1985 TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE MILES LABORATORIES, INC.
K852747 06/27/1985 VISIDEX II REAGENT STRIPS MILES LABORATORIES, INC.
K852946 07/11/1985 SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT MILES LABORATORIES, INC.
K853021 07/18/1985 OPTIMATE DIGOXIN TEST MILES LABORATORIES, INC.
K873304 08/18/1987 CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) MILES LABORATORIES, INC.
K863842 10/01/1986 SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT MILES LABORATORIES, INC.
K864530 11/17/1986 SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. MILES LABORATORIES, INC.
K874909 12/01/1987 MICRO-BUMINTEST REAGENT TABLETS MILES LABORATORIES, INC.
K875079 12/09/1987 MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE MILES LABORATORIES, INC.
K844907 12/17/1984 CLINIFACTS 10 DATA MANAGEMENT SYSTEM MILES LABORATORIES, INC.
K844955 12/21/1984 SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & MILES LABORATORIES, INC.
K865020 12/23/1986 SERA-TEK THYROGLOBULIN ANTIBODY TEST MILES LABORATORIES, INC.
K865053 12/24/1986 SERA-TEK MICROSOMAL ANTIBODY TEST MILES LABORATORIES, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact