FDA 510(k) Applications for Medical Device Product Code "JHS"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K082226 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. | S40 CREATINE KINASE (CK) | 09/18/2008 |
K990439 | CARESIDE, INC. | CARESIDE CK | 04/19/1999 |
K990434 | CARESIDE, INC. | CARESIDE CKMB | 04/19/1999 |
K962126 | CIBA CORNING DIAGNOSTICS CORP. | ACS CKMB II IMMUNOASSAY | 06/21/1996 |
K062128 | DADE BEHRING, INC. | THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS | 08/21/2006 |
K981495 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) | 06/10/1998 |
K160570 | Roche Diagnostics Operations (RDO) | Creatine Kinase | 05/25/2016 |
K102706 | SENTINEL CH. SpA | CKMB UDR ASSAY | 08/19/2011 |