Medical Device Manufacturer · US , Palm Beach Gardens , FL

Triangle Biomedical Sciences, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1996

Recent clearances: MICRO21 WITH URINE SEDIMENT ANALYSIS, MICRO21 WITH WBC ESTIMATE, MICRO21 WITH CEREBROSPINAL FLUID

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Triangle Biomedical Sciences, Inc. Hematology ✕

5 devices

1-5 of 5

Cleared Aug 07, 1998

MICRO21 WITH URINE SEDIMENT ANALYSIS

Hematology · 37d

Cleared Nov 07, 1997

MICRO21 WITH WBC ESTIMATE

Hematology · 84d

Cleared Sep 16, 1997

MICRO21 WITH CEREBROSPINAL FLUID

Hematology · 147d

Cleared May 22, 1996

MICRO21 WITH ANA

Hematology · 86d

Cleared May 17, 1996

MICRO21 WITH RETIC

Hematology · 81d