Medical Device Manufacturer · US , Rochester , NY

Johnson & Johnson Clinical Diagnostics, Inc. - FDA 510(k) Cleared Dev...

33 submissions · 33 cleared · Since 1995

33

Total

33

Cleared

0

Denied

33 devices

26-33 of 33

Cleared May 07, 1996

EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE

Chemistry · 39d

Cleared Dec 18, 1995

EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN

Toxicology · 52d

Cleared Jul 31, 1995

EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)

Immunology · 21d

Cleared Jul 26, 1995

AMERLITE TBG ASSAY

Chemistry · 71d

Cleared Jul 17, 1995

AMERLITE HCG-60 ASSAY

Chemistry · 62d

Cleared Jul 14, 1995

AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)

Chemistry · 64d

Cleared Jul 03, 1995

AMERLITE FSH ASSAY

Chemistry · 48d

Cleared Jun 20, 1995

AMERLITE FERRITIN II ASSAY

Immunology · 35d