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FDA 510(k) Applications Submitted by BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K971761
05/12/1997
PERSONALLAB AUTOMATED MICROPLATE ANALYZER
BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
K954065
08/30/1995
BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
K955102
11/08/1995
BIODATA TESTOSTERONE MAIA KIT
BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
K960072
01/05/1996
SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
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