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

FDA 510(k) Regulatory Record - Miles Laboratories, Inc. Toxicology ✕

30 devices

1-12 of 30

Cleared Jan 14, 1987

SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT

Toxicology · 105d

Cleared Sep 30, 1985

SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT

Toxicology · 81d

Cleared Aug 07, 1985

OPTIMATE DIGOXIN TEST

Toxicology · 20d

Cleared Mar 19, 1985

SERALYZER ARIS PHENYTOIN REAGENT STRIPS

Toxicology · 299d

Cleared Aug 17, 1984

AMES TDA PHENOBARBITAL TEST

Toxicology · 45d

Cleared May 11, 1984

OPTIMATE DIGOXIN TEST

Toxicology · 24d

Cleared Mar 19, 1984

SERALYZER THEOPHYLLINE REAGENT STRIPS

Toxicology · 213d

Cleared Mar 19, 1984

SERALYZER DRUG ASSAY CONTROL SERUM

Toxicology · 123d

Cleared Sep 29, 1983

AMES TDA DISOPYRAMIDE TEST

Toxicology · 44d

Cleared Aug 08, 1983

VISIDEX II REAGENT STRIPS

Toxicology · 48d

Cleared Jun 30, 1983

AMWA TDA THEOPHYLLINE TEST

Toxicology · 49d

Cleared Nov 29, 1982

CLINISTAT TDA SERIES

Toxicology · 39d