Medical Device Manufacturer · US , Mchenry , IL

Nova Biomedical Corp. - FDA 510(k) Cleared Devices

89 submissions · 89 cleared · Since 1977

89

Total

89

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nova Biomedical Corp. Hematology ✕

8 devices

1-8 of 8

Cleared Dec 02, 1999

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1...

Hematology · 77d

Cleared May 12, 1998

STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS

Hematology · 26d

Cleared May 12, 1998

STAT PROFILE M ANALYZER

Hematology · 26d

Cleared Jun 28, 1996

STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS

Hematology · 39d

Cleared Apr 25, 1996

NOVA CO-OXIMETER ANALYZER

Hematology · 176d

Cleared Oct 08, 1991

NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL

Hematology · 77d

Cleared Jan 24, 1989

NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS

Hematology · 81d

Cleared Nov 12, 1985

ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT

Hematology · 134d