Medical Device Manufacturer · US , Irvine , CA

Sage Biopharma - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1999

Recent clearances: SERUM PROTEIN SUBSTITUTE, MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE, WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sage Biopharma Obstetrics & Gynecology ✕

6 devices

1-6 of 6

Cleared Dec 21, 2000

SERUM PROTEIN SUBSTITUTE

Obstetrics & Gynecology · 17d

Cleared Oct 03, 2000

MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE

Obstetrics & Gynecology · 21d

Cleared Feb 15, 2000

WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L

Obstetrics & Gynecology · 300d

Cleared Feb 02, 2000

HYALURONIDASE, 80 U/ML

Obstetrics & Gynecology · 287d

Cleared Jan 18, 2000

1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING...

Obstetrics & Gynecology · 272d

Cleared Sep 24, 1999

PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM,...

Obstetrics & Gynecology · 156d