Medical Device Manufacturer · US , Indianapolis , IN

Universal Reagents, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1996

Recent clearances: UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA, FACTOR DEFICIENT PLASMAS - FACTOR XI (11), FACTOR DEFICIENT PLASMAS - FACTOR IX (9)

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Universal Reagents, Inc. Hematology ✕

8 devices

1-8 of 8

Cleared Sep 25, 1997

UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA

Hematology · 34d

Cleared Jul 14, 1997

FACTOR DEFICIENT PLASMAS - FACTOR XI (11)

Hematology · 25d

Cleared Jul 14, 1997

FACTOR DEFICIENT PLASMAS - FACTOR IX (9)

Hematology · 25d

Cleared Apr 25, 1997

UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA

Hematology · 66d

Cleared Apr 25, 1997

UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA

Hematology · 66d

Cleared Dec 18, 1996

UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA

Hematology · 54d

Cleared Dec 18, 1996

UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA

Hematology · 41d

Cleared Oct 10, 1996

FACTOR DEFICIENT PLASMA

Hematology · 146d