Medical Device Manufacturer · US , Riverdale , UT

In-Line Diagnostics Corp. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1995

Recent clearances: CRIT-LINE MONITOR III (CLM III), CRIT-SCAN II MONITOR, MODIFICATION OF CRIT-LINE MONITOR III (CLM III)

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - In-Line Diagnostics Corp. Gastroenterology & Urology ✕

6 devices

1-6 of 6

Cleared Dec 20, 2000

CRIT-LINE MONITOR III (CLM III)

Gastroenterology & Urology · 191d

Cleared Jul 30, 1999

CRIT-LINE MONITOR III (CLM III)

Gastroenterology & Urology · 28d

Cleared Oct 09, 1998

MODIFICATION OF CRIT-LINE MONITOR III (CLM III)

Gastroenterology & Urology · 88d

Cleared Dec 11, 1997

CRIT-LINE MONITOR (CLMIII)

Gastroenterology & Urology · 163d

Cleared Jul 23, 1996

CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)

Gastroenterology & Urology · 391d

Cleared Jan 19, 1995

CRIT-LINE BLOOD CHAMBER WITH E-BEAM

Gastroenterology & Urology · 419d