Product code CEP— Clinical Chemistry
LH RIA
- Classification name
- Radioimmunoassay, Luteinizing Hormone
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Total cleared
- 143
- First cleared
- Most recent
Market context for product code CEP
FDA has cleared devices under product code CEP between 1977 and 2003, filed by 88 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- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
Top applicants under product code CEP
Recent clearances under product code CEP
1–100 of 143- K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE
- K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST
- K021409 — AT HOME OVULATION TEST, MODEL 9032
- K013874 — CLEARPLANE EASY OVULATION TEST
- K013323 — TCI-31 LIFELONG OVULATION TESTER
- K012252 — QUIK-CHECK OVULATION PREDICTOR
- K010244 — SURE CHECK OVULATION PREDICTOR
- K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST
- K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
- K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
- K990249 — OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031
- K983113 — BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
- K981271 — CLEARPLAN EASY OVULATION TEST
- K974508 — DBEST ONE-STEP OVULATION TEST
- K973310 — TBD* ONE-STEP OVULATION PREDICTOR TEST
- K970467 — EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
- K964982 — VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
- K964694 — ELECSYS LH ASSAY
- K964925 — SEALITE SCIENCES, INC. AQUALITE LH
- K963693 — OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST
- K962866 — OPUS HLH
- K962041 — ACS LH2 IMMUNOASSAY
- K960233 — MINICLINIC OVULATION PREDICTOR
- K961109 — ACTIVE LH IRMA
- K953581 — FIRST RESPONSE OVULATION PREDICTOR TEST
- K953063 — CONCEIVE OVULATION PREDICTOR
- K951538 — BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT
- K951748 — COAT-A-COUNT LH IRMA
- K935319 — CHEMILUMINESCENCE LH
- K943252 — PRO-STEP LH OVULATION PREDICTION TEST
- K943188 — SEALITE SCIENCE, INC. AQUALITE(R) LH
- K943996 — DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
- K942638 — SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
- K940549 — ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
- K935134 — ONE STEP LH TEST
- K926394 — VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
- K930306 — COBAS CORE LH EIA
- K930185 — OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP
- K922944 — IMMUCHEM LH-MW ELISA
- K920920 — ELISA TUBE LH TEST KIT
- K921176 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
- K920160 — LH GEN III SELF-TEST/CONCEIVE
- K920411 — IMMULITE HLH
- K920504 — MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
- K913938 — OPUS(R) LH TEST SYSTEM
- K911050 — LH IRMA IMMUNOMAG
- K910351 — MINICLINIC OVULATION PREDICTION TEST
- K910717 — PANTEX IRMA LH 1251 KIT
- K910198 — CIBA CORNING ACS LH IMMUNOASSAY
- K904387 — BIOCLONES ELEGANCE LH ELISA KIT
- K902786 — MILENIA (TM) LH
- K903052 — IMMUNOCORP LH IRMA COATED TUBE
- K902443 — LUMATAG(TM) LH DIAGNOSTIC KIT
- K902208 — MODIFIED OVUGEN
- K902398 — CIBA CORNING MAGIC LITE LH IMMUNOASSAY
- K900779 — ENZYMUN TEST(R) LH
- K900621 — FIAGEN(TM) HLH.S
- K896866 — LUTEINIZING HORMONE-EIA-XT
- K896642 — MODIFIED LH ENZYME IMMUNOASSAY TEST KIT
- K895094 — TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
- K894579 — CLEARPLAN EASY
- K894279 — LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
- K891762 — MINICLINIC OVULATION PREDICTION TEST
- K893605 — SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
- K890510 — ABBOTT OVULATION PREDICTOR TEST
- K883814 — DELFIA HLH SPEC KIT
- K884498 — COTUBE LH IRMA ASSAY
- K883530 — FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
- K884138 — ABBOTT IMX LH
- K882340 — LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
- K882252 — PHASE II LH KIT
- K880933 — AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
- K880758 — SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
- K881124 — ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
- K874624 — FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301
- K874032 — IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
- K870584 — O.P.T.(TM) OVULATION PREDICTION TEST
- K873534 — OVUGEN SURETEST
- K873668 — MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
- K871241 — ANSWER OVULATION TEST KIT
- K873186 — LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
- K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
- K872131 — TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
- K871332 — CLEARPLAN
- K872727 — LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
- K871726 — OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)
- K871602 — MICROCHECK LH OVULATION TEST
- K863934 — DPC COAT-A-COUNT IRMA LH KIT
- K863442 — UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE
- K862055 — CANWEST OVU-BLUE
- K864144 — LUTEINIZING HORMONE (LH-IRMA) RIA KIT
- K863929 — TERUMO SENSIBEAD(TM) EIA HLH KIT
- K863679 — ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
- K861354 — RIGHT-DAY OVULATION HOME TEST
- K860828 — FORETEL, COLOR OVULATION TEST
- K860538 — RIGHT-DAY URINARY LH (EIA)
- K862180 — MODIFIED COTROPIN RADIOIMMUNOASSAY KIT
- K860984 — TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
- K860333 — MICRO-ELISA HLH TEST KIT MONOCLONAL
- K860334 — VISI-CHECK HLH TEST MONOCLONAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.