Miles Laboratories, Inc. - FDA 510(k) Cleared Devices
158
Total
158
Cleared
0
Denied
158 devices
Cleared
Sep 20, 1983
SERA-TEK MYCOPLASMA ANTIBODY TEST
Immunology
81d
Cleared
Sep 08, 1983
DIASTIX REAGENT STRIPS FOR URINALYSIS
Chemistry
113d
Cleared
Aug 11, 1983
SERALYZER MULTICOMPONENT CALIBRATORS
Chemistry
48d
Cleared
Aug 08, 1983
VISIDEX II REAGENT STRIPS
Toxicology
48d
Cleared
Jul 28, 1983
TISSUE-TEK V.I.P. 100/200
Pathology
97d
Cleared
Jun 30, 1983
AMWA TDA THEOPHYLLINE TEST
Toxicology
49d
Cleared
Jun 02, 1983
AMES TDA N-ACETYL-PROCAINAMIDE TEST
Immunology
34d
Cleared
Jun 02, 1983
AMES TDA PROCAINAMIDE TEST
Immunology
34d
Cleared
May 25, 1983
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
Microbiology
76d
Cleared
Apr 12, 1983
AMES TDA VALPROIC ACID TEST
Chemistry
29d
Cleared
Jan 14, 1983
AMES TDA ETHOSUXIMIDE TEST
Chemistry
28d
Cleared
Dec 15, 1982
AMES TDA GENTAMICIN TEST
Chemistry
191d
Cleared
Nov 29, 1982
CLINISTAT TDA SERIES
Toxicology
39d
Cleared
Oct 08, 1982
FLUOROSTAT FLUOROMETER
Chemistry
31d
Cleared
Jul 30, 1982
SERALYZER HEMOGLOBIN REAGENT STRIPS
Hematology
18d
Cleared
Jul 30, 1982
SERALYZER HEMOGLOBIN TEST MODULE
Hematology
18d
Cleared
Jul 30, 1982
SERALYZER HEMOGLOBIN CALIBRATORS
Hematology
18d
Cleared
Jul 06, 1982
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST
Chemistry
22d
Cleared
May 21, 1982
ACCUDEX REAGENT STRIPS
Chemistry
22d
Cleared
May 14, 1982
VISIDEX REAGENT STRIPS
Chemistry
17d
Cleared
Apr 16, 1982
SERALYZER CK REAGENT STRIPS
Chemistry
17d
Cleared
Jan 26, 1982
SERALYZER CREATININE REAGENT STRIPS
Chemistry
14d
Cleared
Jan 18, 1982
Q-LINE LTC
Chemistry
25d
Cleared
Oct 19, 1981
AMES TDA QUINIDINE TEST
Toxicology
20d
Cleared
Sep 29, 1981
TISSUE-TEK III ACCU-CUT ROTARY MICROTOME
Hematology
21d
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