FDA 510(k) Applications Submitted by STEPHEN L DUFF

FDA 510(k) Number Submission Date Device Name Applicant
K032804 09/09/2003 CRYOCHECK WEAK LUPUS POSITIVE CONTROL PRECISION BIOLOGIC
K060284 02/03/2006 CRYOCHECK CLOT APCR PRECISION BIOLOGIC INC.
K971219 04/02/1997 CRYO CHECK INR VALIDATION SET PRECISION BIOLOGICALS, INC.
K971222 04/02/1997 CRYO CHECK APC RESISTANT PLASMA PRECISION BIOLOGICALS, INC.
K971223 04/02/1997 CRYO CHECK FACTOR V DEFICIENT PLASMA PRECISION BIOLOGICALS, INC.
K971224 04/02/1997 CRYO CHECK FACTOR VII DEFICIENT PLASMA PRECISION BIOLOGICALS, INC.
K971225 04/02/1997 CRYO CHECK FACTOR VIII DEFICIENT PLASMA PRECISION BIOLOGICALS, INC.
K971226 04/02/1997 CRYO CHECK FACTOR IX DEFICIENT PLASMA PRECISION BIOLOGICALS, INC.
K971227 04/02/1997 CRYO CHECK FACTOR X DEFICIENT PLASMA PRECISION BIOLOGICALS, INC.
K040987 04/15/2004 CRYOCHECK CLOT C PRECISION BIOLOGIC INC.
K951823 04/20/1995 CRYO CHECK LOW FIBRINOGEN CONTROL PRECISION BIOLOGICALS, INC.
K013708 11/08/2001 REFERENCE CHECK, CATALOG NUMBER-RCN-10 PRECISION BIOLOGIC
K023990 12/03/2002 CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 PRECISION BIOLOGIC
K023991 12/03/2002 CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 PRECISION BIOLOGIC
K043571 12/27/2004 CRYOCHECK CLOT S PRECISION BIOLOGIC INC.


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