FDA 510(k) Applications for Medical Device Product Code "CIN"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K994278 | BECKMAN COULTER, INC. | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY | 03/28/2000 |
K964764 | BEHRING DIAGNOSTICS, INC. | OPUS BONE ALP | 01/24/1997 |
K020625 | HELENA LABORATORIES | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 | 05/06/2002 |
K972666 | HYBRITECH, INC. | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | 09/11/1997 |
K961573 | HYBRITECH, INC. | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | 08/19/1996 |
K200475 | Immunodiagnostic Systems Ltd. | IDS-iSYS Ostase BAP | 09/30/2020 |
K981373 | METRA BIOSYSTEMS, INC. | ALKPHASE-B ASSAY KIT | 05/27/1998 |
K043125 | ORION DIAGNOSTICA OY | ORION DIAGNOSTICA UNIQ PINP RIA | 05/04/2005 |
K011113 | SEBIA | HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) | 06/13/2001 |