Product code CGJ— Clinical Chemistry
FSH RIA
- Classification name
- Radioimmunoassay, Follicle-Stimulating Hormone
- Device class
- Class 1
- Regulation
- 21 CFR 862.1300
- Advisory panel
- Clinical Chemistry
- Total cleared
- 88
- First cleared
- Most recent
Market context for product code CGJ
FDA has cleared devices under product code CGJ between 1976 and 2005, filed by 61 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2005
- 2004
- 2003
- 2001
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
Top applicants under product code CGJ
Recent clearances under product code CGJ
- K052662 — ONE STEP FSH MENOPAUSAL TEST
- K043599 — MOMENTS MENOPAUSE CHECK, MODEL 9113
- K041165 — FSH MENOPAUSE PREDICTOR TEST
- K040575 — PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
- K030058 — EARLYDETECT MENOPAUSE TEST FOR FSH
- K002450 — GENUA MENOPAUSE MONITOR TEST KIT
- K972720 — FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
- K970085 — SEALITE SCIENCES AQUALITE FSH
- K964720 — VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
- K964693 — ELECSYS FSH ASSAY
- K962118 — DSL ACTIVE FSH IRMA
- K952285 — AMERLITE FSH ASSAY
- K943437 — AQUALITE FSH
- K941221 — DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE
- K935612 — AXSYM FOLLICLE STIMULATING HORMONE (FSH)
- K940005 — ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
- K930304 — COBAS CORE FSH EIA
- K922376 — ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT
- K921746 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
- K921704 — IMMULITE(R) FSH
- K920917 — ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY
- K915208 — FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057
- K912804 — FSH IRMA IMMUNOMAG
- K911409 — OPUS FSH
- K905814 — LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY
- K905592 — AFFINITY FSH TEST SYSTEM
- K904649 — CIBA CORNING ACS FSH IMMUNOASSAY
- K904405 — BIOCLONES ELEGANCE FSH ELISA KIT
- K901345 — MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050
- K900763 — ENZYMUN TEST(R) FSH
- K896864 — FOLLICLE STIMULATING HORMONE-EIA-XT
- K896640 — MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT
- K895005 — MILENIA(TM) FSH (MKFS1,5)
- K895108 — FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.
- K894761 — TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
- K893976 — COAT-A-COUNT (TM) FSH IRMA
- K892706 — SR1 (FSH) IMMUNOENZYMETRIC ASSAY
- K890135 — IMX FOLLICLE STIMULATING HORMONE (FSH)
- K884708 — FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT
- K884687 — CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
- K883745 — IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
- K883305 — BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
- K883279 — PHASE II FSH KIT
- K881142 — AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST
- K881596 — FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057
- K881123 — ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
- K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY
- K872309 — MICROMEDIC COMBOSTAT LH/FSH KIT
- K872627 — FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH
- K871317 — FOLLICLE STIMULATING HORMONE (HFSH)
- K870520 — TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY
- K863928 — TERUMO SENSIBEAD EIA FSH KIT
- K864080 — UBI MAGIWEL(TM) FSH QUANTITATIVE
- K863678 — FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
- K862813 — FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT
- K862439 — SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA
- K862043 — DELFIA (TM) HFSH KIT
- K854837 — LEE-BEAD BETA FSH (EIA)
- K854651 — PARAAMAX CHLORIDE DETERMINATION BY ISE
- K851361 — AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM
- K844066 — COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH
- K843930 — IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I
- K842444 — FSH RIA
- K840230 — FSH QUIK RIA KIT
- K834038 — RIANEN FOLLICLE STIMULATING HORMONE
- K833852 — FSH RIA
- K831742 — QUANTIMUNE HFSH RIA HUMAN FOLLICLE-
- K823379 — 125-I FSH RADIOIMMUNOASSAY KIT
- K822227 — IMMO PHASE FSH RADIOIMMUNOASSAY
- K821611 — GAMMADAB [125] FSH RADIOIMMUNAY KIT
- K820754 — AMERLEX ESH KIT
- K820740 — MR1 FOLLITROPIN RIA KIT
- K820358 — FOLLICLE STIMULATING HORMONE KIT
- K820048 — FSH RADIOIMMUNOASSAY TEST SYSTEM
- K813086 — ANDRIA-FSH RIA TEST KIT
- K811993 — RADIOIMMUNOASSAY, FOLLICLE STIMULATING
- K811905 — FOLLICLE STIMULATING HORMONE DIRECT RIA
- K810852 — FOLLICLE STIMULATING HORMONE ANTISERUM
- K810663 — LEECO FSH-QUANT DIAGNOSTIC KIT
- K810381 — HTSH RIABEAD DIAGNOSTIC KIT
- K803279 — FOLLICE STIMULATING HORMONE-RADIOIMM. KT
- K800107 — FOLLICLE STIMULATING HORMONE
- K792233 — CENTRIA FSH RIA
- K792063 — FOLLICLE STIMULATING HORMONE (FSH) KIT
- K791836 — QUANTIMUNE HFSH RIA
- K780870 — RIA SYSTEM FOR HUMAN F-S HORMONE
- K771756 — FOLLICLE-STIMULATING HORMONE
- K760373 — RADIOASSAY KIT, IM.72 FSH
Data sourced from openFDA. This site is unofficial and independent of the FDA.