Medical Device Manufacturer · US , Walker , MI

Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

288 submissions · 288 cleared · Since 1984

288

Total

288

Cleared

0

Denied

288 devices

276-288 of 288

Cleared Sep 13, 1984

SYSTEMATE LDH, 67210

Chemistry · 24d

Cleared Sep 13, 1984

SYSTEMATE ALKALINE PHOSPHATASE-67203

Chemistry · 24d

Cleared Sep 13, 1984

SYSTEMATE URIC ACID, HEM 67220

Chemistry · 17d

Cleared Sep 07, 1984

SYSTEMATE CK-TOTAL - 67206

Chemistry · 18d

Cleared Aug 29, 1984

SYSTEMATE CALCIUM 67214

Chemistry · 19d

Cleared Aug 27, 1984

SYSTEMATE CREATININE 67223

Chemistry · 20d

Cleared Aug 27, 1984

SYSTEMATE TRIGLYCERIDE 67219

Chemistry · 20d

Cleared Aug 27, 1984

SYSTEMATE TOTAL PROTEIN 67218

Chemistry · 20d

Cleared Aug 27, 1984

SYSTEMATE ALBUMIN

Chemistry · 20d

Cleared Aug 27, 1984

SYSTEMATE GLUCOSE 67216

Chemistry · 17d

Cleared Aug 27, 1984

SYSTEMATE GLUCOSE 67215

Chemistry · 17d

Cleared Jul 06, 1984

ULTRA CHEM ENZYMATIC TRIGLYCERIDE

Chemistry · 32d

Cleared May 16, 1984

ULTRA CHEM ENZYMATIC TRIGLYCERIDE

Chemistry · 37d

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