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FDA 510(k) Applications Submitted by STEPHEN 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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