Medical Device Manufacturer · US , Mchenry , IL

Miles Laboratories, Inc. - FDA 510(k) Cleared Devices

158 submissions · 158 cleared · Since 1976
158
Total
158
Cleared
0
Denied
158 devices
101-125 of 158
Cleared Aug 20, 1980
SERALYZER GLUCOSE REAGENT STRIPS
K801663 · CGA
Chemistry · 30d
Cleared Aug 20, 1980
SERALYZER GLUCOSE TEST MODULE
K801664 · JQP
Chemistry · 30d
Cleared Aug 20, 1980
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)
K801665 · JIS
Chemistry · 30d
Cleared Aug 20, 1980
AMES TDA TM PHENYTOIN TEST
K801736 · LES
Toxicology · 26d
Cleared Aug 20, 1980
LAB-TEK FTA-ABS KIT
K801928 · JWL
Microbiology · 8d
Cleared Jul 28, 1980
TISSUE-TEK III MICROJECT DISP. BLADE SYS
K801426 · IDL
Pathology · 41d
Cleared Jul 28, 1980
TISSUE-TEK III MINI-RAPID PROCESSOR
K801427 · IEO
Pathology · 41d
Cleared Jul 08, 1980
SERALYZER BLOOD UREA NITROGEN(BUN)
K801269 · JGZ
Chemistry · 41d
Cleared Jul 08, 1980
TEST FOR KETONE IN URINE(ACETOACETIC AC
K801270 · JIN
Chemistry · 41d
Cleared Jun 17, 1980
BIOSTATOR PRINTER/PLOTTER
K801210 · JQP
Chemistry · 28d
Cleared Jun 02, 1980
AMES GLUCOMETER REFLECT. PHOTOMETER
K801044 · JJQ
Chemistry · 28d
Cleared May 28, 1980
AMES TDA AMIKACIN
K801130 · KLQ
Toxicology · 16d
Cleared May 23, 1980
LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE
K800899 · KZJ
Microbiology · 35d
Cleared May 08, 1980
PENTEX BOVINE ALBUMIN 30% SOLUTION
K800943 · KSG
Hematology · 16d
Cleared Apr 24, 1980
SERALYZER URIC ACID REAGENT STRIPS -
K800848 · KNK
Chemistry · 9d
Cleared Apr 16, 1980
AMES LAB MANAGEMENT SYSTEM
K800724 · JQP
Microbiology · 15d
Cleared Apr 10, 1980
AMES TDA THEOPHYL-LINE TEST
K800646 · KLS
Toxicology · 17d
Cleared Apr 04, 1980
COMPUR M-1000 MINI-PHOTOMETER
K800059 · KHG
Hematology · 85d
Cleared Apr 02, 1980
SERALYZER REFLECTANCE PHOTOMETER/CALIB.
K800524 · CIE
Chemistry · 27d
Cleared Feb 13, 1980
AMES RIALYZE - CHROMATOGRAPHY TUBES
K800169 · CDX
Chemistry · 19d
Cleared Feb 13, 1980
AMES RIALYZE - UPTAKE CHROM. TUBES
K800170 · KHQ
Chemistry · 19d
Cleared Jan 21, 1980
PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
K800035 · JJX
Chemistry · 14d
Cleared Dec 06, 1979
AMES DEXTROMETER REFLECTANCE COLORIMETER
K792292 · JJQ
Chemistry · 23d
Cleared Nov 30, 1979
LAB-TEK ANA TEST KIT
K792184 · DHN
Immunology · 32d
Cleared Aug 16, 1979
AMES TDA/TOBRAMYCIN
K791435 · KLB
Toxicology · 16d

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