Biochem Immunosystems (U.S.), Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biochem Immunosystems (U.S.), Inc. - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
Biochem Immunosystems (U.S.), Inc. has 4 FDA 510(k) cleared medical devices. Based in Allentown, US.
Historical record: 4 cleared submissions from 1996 to 1997. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Biochem Immunosystems (U.S.), Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Biochem Immunosystems (U.S.), Inc.
4 devices
Cleared
Jul 22, 1997
PERSONALLAB AUTOMATED MICROPLATE ANALYZER
Chemistry
71d
Cleared
Mar 06, 1997
SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
Hematology
426d
Cleared
Jul 10, 1996
BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
Chemistry
315d
Cleared
Jun 24, 1996
BIODATA TESTOSTERONE MAIA KIT
Chemistry
229d