FDA 510(k) Applications for Medical Device Product Code "CGJ"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K041165 | ACON LABORATORIES, INC. | FSH MENOPAUSE PREDICTOR TEST | 06/17/2004 |
K964693 | BOEHRINGER MANNHEIM CORP. | ELECSYS FSH ASSAY | 12/16/1996 |
K962118 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | DSL ACTIVE FSH IRMA | 09/09/1996 |
K030058 | EARLY DETECT, INC. | EARLYDETECT MENOPAUSE TEST FOR FSH | 07/30/2003 |
K002450 | GENUA 1944, INC. | GENUA MENOPAUSE MONITOR TEST KIT | 01/12/2001 |
K052662 | IND DIAGNOSTIC INC. | ONE STEP FSH MENOPAUSAL TEST | 11/30/2005 |
K964720 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) | 02/04/1997 |
K972720 | MONOBIND | FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) | 09/02/1997 |
K043599 | PHAMATECH INC. | MOMENTS MENOPAUSE CHECK, MODEL 9113 | 02/25/2005 |
K040575 | PHAMATECH INC. | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | 05/20/2004 |
K970085 | SEALITE SCIENCES, INC. | SEALITE SCIENCES AQUALITE FSH | 02/14/1997 |