FDA 510(k) Applications for Medical Device Product Code "CZJ"
(Igd, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K872834 HELENA LABORATORIES TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 08/12/1987
K772327 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R HUMAN IGD TEST 02/28/1978
K883001 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 CALIBRATOR D PACK 09/22/1988
K831956 KENT LABORATORIES, INC. DETERM. SIZE 72 RADIAL-HUMAN IGD 07/18/1983
K092450 THE BINDING SITE HUMAN IGD KIT FOR USE ON SPAPLUS 12/28/2009
K051299 THE BINDING SITE LTD. IGD DIAGNOSTIC TEST KITS 11/23/2005
K913671 THE BINDING SITE, LTD. HUMAN IGD IMMUNOLOGICAL NL TEST KIT 12/02/1991
K002561 THE BINDING SITE, LTD. SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT 10/26/2000


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