Miles Laboratories, Inc. - FDA 510(k) Cleared Devices
158
Total
158
Cleared
0
Denied
79 devices
Cleared
Oct 14, 1983
SERAYZER ALT/SGPT REAGENT STRIPS
Chemistry
56d
Cleared
Oct 04, 1983
SERALYZER TRIGLYCERIDES REAGENT STRIPS
Chemistry
56d
Cleared
Sep 29, 1983
AMES TDA KANAMYCIN TEST-CONTROL SERUM
Chemistry
44d
Cleared
Sep 29, 1983
AMES TDA SISOMICIN TEST-CONTROL SERUM
Chemistry
44d
Cleared
Sep 08, 1983
DIASTIX REAGENT STRIPS FOR URINALYSIS
Chemistry
113d
Cleared
Aug 11, 1983
SERALYZER MULTICOMPONENT CALIBRATORS
Chemistry
48d
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
Oct 08, 1982
FLUOROSTAT FLUOROMETER
Chemistry
31d
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
Sep 23, 1981
AMES TDA THEOPHYLLINE TEST
Chemistry
21d
Cleared
Sep 01, 1981
REAGENT STRIPS FOR URINALYSIS
Chemistry
112d
Cleared
Aug 12, 1981
SERALYZER
Chemistry
19d
Cleared
May 29, 1981
AMES SERA-PAK GLUCOSE REAGENT
Chemistry
11d
Cleared
Mar 31, 1981
SERALYZER SYSTEM
Chemistry
21d
Cleared
Dec 22, 1980
SERALYZER LDH REAGENT STRIPS, CALIBR
Chemistry
24d
Cleared
Dec 22, 1980
AMES TDA AMIKACIN CONTROL SERUM
Chemistry
12d
Cleared
Dec 11, 1980
SERA-PAK TOTAL PROTEIN REAGENT
Chemistry
38d
Cleared
Dec 10, 1980
AMES SERA-PAK CHOLESTEROL REAGENT KIT
Chemistry
37d
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