FDA 510(k) Applications for Medical Device Product Code "DBI"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K983356 | ABBOTT LABORATORIES | C4 | 11/04/1998 |
K964297 | CRESTAT DIAGNOSTICS, INC. | N-ASSAY TIA C4 TEST KIT | 07/14/1997 |
K964300 | CRESTAT DIAGNOSTICS, INC. | N-ASSAY TIA MULTI V-NL | 07/14/1997 |
K994293 | DADE BEHRING, INC. | DIMENSION C4 FLEX REAGENT CARTRIDGE | 03/01/2000 |
K962198 | INSTRUMENTATION LABORATORY CO. | QUANTEX C4 | 09/26/1996 |
K993481 | KAMIYA BIOMEDICAL CO. | K-ASSAY C4 | 11/29/1999 |
K962582 | OLYMPUS AMERICA, INC. | OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT | 10/18/1996 |
K000468 | RANDOX LABORATORIES, LTD. | RANDOX COMPLEMENT C4 | 03/27/2000 |
K012359 | ROCHE DIAGNOSTICS CORP. | TINA-QUANT COMPLEMENT C4 TEST SYSTEM | 11/29/2001 |
K100455 | THE BINDING SITE | SPAPLUS ANALYZER | 09/03/2010 |
K981785 | THE BINDING SITE, LTD. | C4 MININEPH ANTISERUM | 12/20/1999 |
K010325 | WAKO CHEMICALS, USA, INC. | WAKO AUTOKIT C4 | 06/25/2001 |