Medical Device Manufacturer · US , Allentown , PA

Biochem Immunosystems (U.S.), Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1996

Recent clearances: PERSONALLAB AUTOMATED MICROPLATE ANALYZER, SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX, BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biochem Immunosystems (U.S.), Inc. Hematology ✕

1 devices

1-1 of 1

Cleared Mar 06, 1997

SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX

Hematology · 426d