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
79 devices
51-75 of 79
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 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 Apr 24, 1980
SERALYZER URIC ACID REAGENT STRIPS -
K800848 · KNK
Chemistry · 9d
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 Jun 28, 1979
REAGENT STRIPS FOR URINALYSIS
K790965 · CDM
Chemistry · 37d
Cleared May 15, 1979
CHROMATOGRAPHY TUBES
K790581 · CDP
Chemistry · 49d
Cleared Feb 08, 1979
CONTROL STRIP FOR VISUAL URINALYSIS
K781961 · JJW
Chemistry · 79d
Cleared Aug 14, 1978
CLINIRIA T-3 UPTAKE TEST
K781180 · KHQ
Chemistry · 31d
Cleared Aug 14, 1978
CLINIRIA TOTAL T-4 (RIA) TEST
K781181 · CDX
Chemistry · 31d
Cleared Jan 26, 1978
PRINTER
K772099 · JJJ
Chemistry · 80d
Cleared Oct 25, 1977
9-WAY URINE TEST WITH ASCORBIC
K771755 · JIL
Chemistry · 39d
Cleared Oct 25, 1977
SERALUTE TSH (RIA)
K771767 · JLW
Chemistry · 36d
Cleared Oct 18, 1977
TEK-CHEK-2
K771713 · JJW
Chemistry · 36d
Cleared Sep 12, 1977
AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI
K771004 · CDT
Chemistry · 102d
Cleared May 03, 1977
URINALYSIS PROFICIENCY
K770390 · JJW
Chemistry · 64d
Cleared Mar 21, 1977
CLINILAB AUTOMATED URINALYSIS SYSTEM
K761306 · KQO
Chemistry · 89d

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