Medical Device Manufacturer · US , Irvine , CA

Sage Biopharma - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1999

Recent clearances: WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L, HYALURONIDASE, 80 U/ML, 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI

6

Total

6

Cleared

0

Denied

Sage Biopharma has 6 FDA 510(k) cleared medical devices. Based in Irvine, US.

Historical record: 6 cleared submissions from 1999 to 2000. Primary specialty: Obstetrics & Gynecology.

Browse the FDA 510(k) cleared devices submitted by Sage Biopharma Filter by specialty or product code using the sidebar.

Sage Biopharma is one of 9146 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Sage Biopharma

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