Medical Device Manufacturer · US , Elkhart , IN

Heraeus Kulzer, Inc. - FDA 510(k) Cleared Devices

145 submissions · 145 cleared · Since 1988

145

Total

145

Cleared

0

Denied

FDA 510(k) Regulatory Record - Heraeus Kulzer, Inc. Hematology ✕

8 devices

1-8 of 8

Cleared Jul 19, 1994

AMES DCA 2000 HEMOGLOBIN ALC CONTROLS

Hematology · 139d

Cleared Jun 22, 1993

TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)

Hematology · 132d

Cleared May 11, 1993

TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)

Hematology · 119d

Cleared Sep 11, 1992

Hematology · 71d

Cleared May 15, 1992

SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5

Hematology · 74d

Cleared Sep 05, 1991

AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM

Hematology · 147d

Cleared Sep 11, 1990

OPTIMATE HEMOGLOBIN A1C

Hematology · 281d

Cleared Feb 24, 1989

CLINISTAT HEMOGLOBIN REAGENT TEST

Hematology · 66d