FDA 510(k) Applications Submitted by KENNETH B ASARCH

FDA 510(k) Number Submission Date Device Name Applicant
K950671 02/13/1995 IMMULITE TOXOPLASMA GONDII IGG DIAGNOSTIC PRODUCTS CORP.
K990009 01/04/1999 CARESIDE AST CARESIDE, INC.
K990025 01/04/1999 CARESIDE AMYLASE CARESIDE, INC.
K990024 01/05/1999 CARESIDE ALKALINE PHOSPHATASE CARESIDE, INC.
K980041 01/06/1998 CARESIDE ALBUMIN EXIGENT DIAGNOSTICS, INC.
K980042 01/06/1998 CARESIDE TOTAL PROTEIN EXIGENT DIAGNOSTICS, INC.
K980043 01/06/1998 CARESIDE CREATININE EXIGENT DIAGNOSTICS, INC.
K980055 01/06/1998 CARESIDE GLOBULIN EXIGENT DIAGNOSTICS, INC.
K980056 01/06/1998 CARESIDE ANALYZER EXIGENT DIAGNOSTICS, INC.
K980057 01/06/1998 CARESIDE BUN EXIGENT DIAGNOSTICS, INC.
K990036 01/06/1999 CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 CARESIDE, INC.
K990434 02/11/1999 CARESIDE CKMB CARESIDE, INC.
K990439 02/11/1999 CARESIDE CK CARESIDE, INC.
K950670 02/13/1995 IMMULITE HERPES I AND II IGG DIAGNOSTIC PRODUCTS CORP.
K020484 02/13/2002 CARESIDE LDH CARESIDE, INC.
K020486 02/13/2002 CARESIDE GGT CARESIDE, INC.
K020487 02/13/2002 CARESIDE ALT CARESIDE, INC.
K020488 02/13/2002 CARESIDE TRGLYCERIDE CARESIDE, INC.
K981183 04/01/1998 CARESIDE GLUCOSE EXIGENT DIAGNOSTICS, INC.
K981604 04/28/1998 CARESIDE URIC ACID CARESIDE, INC.
K981610 04/30/1998 CARESIDE ANALYZER CARESIDE, INC.
K981588 05/04/1998 CARESIDE TOTAL BILIRUBIN CARESIDE, INC.
K001462 05/10/2000 CARESIDE HEMOGLOBIN CARESIDE, INC.
K991717 05/20/1999 CARESIDE MG CARESIDE, INC.
K981899 06/01/1998 CARESIDE HDL-CHOLESTEROL EXIGENT DIAGNOSTICS, INC.
K982118 06/03/1998 CARESIDE ANALYZER EXIGENT DIAGNOSTICS, INC.
K992475 07/26/1999 CARESIDE CO2, TOTAL CARESIDE, INC.
K002792 09/07/2000 CARESIDE CHOLINESTERASE CARESIDE, INC.
K993634 10/27/1999 CARESIDE ANALYZER CARESIDE, INC.
K993771 11/08/1999 CARESIDE DIRECT BILIRUBIN CARESIDE, INC.
K014028 12/06/2001 CARESIDE APTT CARESIDE HEMOTOLOGY, INC.
K983789 10/27/1998 CARESIDE CALCIUM, ORIGINAL CARESIDE, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact