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Biocheck, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K041619 BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116MMI2004-12-17 View
510(k) K040030 BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114DCN2004-06-16 View
510(k) K022660 BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117DRR2002-12-19 View
510(k) K013062 BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KITMMI2002-01-08 View
510(k) K003851 BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119DCK2001-07-20 View
510(k) K002294 BIOCHECK TESTOSTERONE EIA, MODEL BC-1115CDZ2000-10-02 View
510(k) K001022 BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061JZG2000-09-26 View
510(k) K992517 BIOCHECK FERRITIN ELISA MODEL BC-1025DBF1999-09-24 View
510(k) K992528 BIOCHECK IGE ELISA, MODEL BC-1035DGC1999-09-21 View
510(k) K991741 BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHI1999-07-22 View
510(k) K991146 TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLW1999-06-22 View
510(k) K990993 BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLW1999-06-22 View
510(k) K991432 BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLI1999-06-02 View
510(k) K991311 TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDP1999-06-02 View
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