Medical Device Manufacturer · US , Indianapolis , IN

Roche Diagnostics Corp. - FDA 510(k) Cleared Devices

264 submissions · 263 cleared · Since 1999
264
Total
263
Cleared
1
Denied
52 devices
51-52 of 52
Cleared Feb 26, 1999
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544,...
K990377 · DIF
Toxicology · 18d
Cleared Feb 23, 1999
ONTRAK TESTCUP-5 M2K
K990337 · DKZ
Toxicology · 20d
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All264 Chemistry 145 Toxicology 52 Immunology 38 Hematology 16 Microbiology 7 General Hospital 4 Pathology 2