Medical Device Manufacturer · TW , Hsin Chu City

Biotop Technology Co., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2004

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biotop Technology Co., Ltd. General Hospital ✕

4 devices

1-4 of 4

Cleared Jan 03, 2007

BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML

General Hospital · 147d

Cleared Dec 22, 2004

BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML

General Hospital · 48d

Cleared Aug 03, 2004

BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND...

General Hospital · 12d

Cleared May 11, 2004

BIOTOP DJT-A SAFETY SYRINGE

General Hospital · 250d