Medical Device Manufacturer · US , Charlottesville , VA

Humagen Fertility Diagnostics, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1994

Recent clearances: BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B, PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75, INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Humagen Fertility Diagnostics, Inc. Obstetrics & Gynecology ✕

4 devices

1-4 of 4

Cleared Feb 11, 2002

BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS...

Obstetrics & Gynecology · 173d

Cleared May 12, 2000

PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9,...

Obstetrics & Gynecology · 51d

Cleared Jul 14, 1999

INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI...

Obstetrics & Gynecology · 121d

Cleared Jul 14, 1999

NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52,...

Obstetrics & Gynecology · 114d