Miles, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
2

Recent 510(k) Clearances

K-NumberDeviceDate
K950292FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEMMay 2, 1995
K950353TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMApril 20, 1995
K950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMarch 13, 1995
K945655CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM)January 5, 1995
K941171TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)December 14, 1994
K943376OPERA SYSTEMSeptember 14, 1994
K941156TECHNISON AXON SYSTEMApril 26, 1994
K933682DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMSApril 12, 1994
K935287IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEMJanuary 3, 1994
K933475TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11November 22, 1993
K933478TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11November 22, 1993