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Miles Laboratories, Inc.

FDA 510(k) & PMA Approved Devices — 158 products

Total Devices158
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K880605 LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERFPB1988-05-26 View
510(k) K874909 MICRO-BUMINTEST REAGENT TABLETSJIR1988-04-28 View
510(k) K875079 MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULECKA1988-04-05 View
510(k) K871835 GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTCGA1987-12-22 View
510(k) K872120 SERALYZER III BLOOD CHEMISTRY ANALYZERJJF1987-10-28 View
510(k) K873304 CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)LJX1987-09-11 View
510(k) K872634 CUTTER PUREFLO PLUS IV FILTERFPB1987-08-04 View
510(k) K870214 MODIFIED SALTEX REAGENT STRIPSCHK1987-06-29 View
510(k) K870752 SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPSCFJ1987-04-14 View
510(k) K864530 SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.CGA1987-02-18 View
510(k) K865053 SERA-TEK MICROSOMAL ANTIBODY TESTJZO1987-02-18 View
510(k) K865020 SERA-TEK THYROGLOBULIN ANTIBODY TESTDDC1987-02-02 View
510(k) K863842 SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONTKLT1987-01-14 View
510(k) K861844 GLUCOFACTS DATA MANAGEMENT SYSTEMJQP1986-08-12 View
510(k) K861779 GLUCOFACTS DATA PRINTERJQP1986-08-08 View
510(k) K861303 GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETERCGA1986-07-02 View
510(k) K861778 CLINIFACTS 200 DATA MANAGEMENT SYSTEMJQP1986-07-02 View
510(k) K855202 GLUCOMETER M BLOOD GULCOSE METERCGA1986-07-02 View
510(k) K855203 GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOODFMK1986-02-11 View
510(k) K855040 SERALYZER TOTAL BILIRUBIN CALIBRATORSJIS1986-01-22 View
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