CEP · Radioimmunoassay, Luteinizing Hormone
Clinical Chemistry · 21 CFR 862.1485 · Class 1
Overview
| Product Code | CEP |
|---|---|
| Device Name | Radioimmunoassay, Luteinizing Hormone |
| Regulation | 21 CFR 862.1485 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 143)
Showing 20 most recent of 143 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013582 | MAYBE?MOM MINI OVULATION MICROSCOPE | Maybe?Mom | Jan 16, 2003 | SESE |
| K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST | Alfa Scientific Designs, Inc. | Nov 5, 2002 | SESE |
| K021409 | AT HOME OVULATION TEST, MODEL 9032 | Phamatech, Inc. | May 24, 2002 | SESE |
| K013874 | CLEARPLANE EASY OVULATION TEST | Unipath , Ltd. | Feb 19, 2002 | SESE |
| K013323 | TCI-31 LIFELONG OVULATION TESTER | Tci New York | Dec 5, 2001 | SESE |
| K012252 | QUIK-CHECK OVULATION PREDICTOR | ACON Laboratories, Inc. | Aug 24, 2001 | SESE |
| K010244 | SURE CHECK OVULATION PREDICTOR | Chembio Diagnostic Systems, Inc. | May 2, 2001 | SESE |
| K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST | Selfcare, Inc. | Oct 12, 2000 | SESE |
| K991466 | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) | Selfcare, Inc. | May 25, 1999 | SESE |
| K991386 | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) | Selfcare, Inc. | May 25, 1999 | SESE |
| K990249 | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 | Phamatech | Mar 22, 1999 | SESE |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | Syntron Bioresearch, Inc. | Nov 18, 1998 | SESE |
| K981271 | CLEARPLAN EASY OVULATION TEST | Unipath , Ltd. | Jun 25, 1998 | SESE |
| K974508 | DBEST ONE-STEP OVULATION TEST | Ameritek, Inc. | Feb 2, 1998 | SESE |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Armkel, LLC | Oct 27, 1997 | SESE |
| K970467 | EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT | Excel Scientific, Inc. | Mar 18, 1997 | SESE |
| K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) | Johnson & Johnson Clinical Diagnostics, Inc. | Feb 20, 1997 | SESE |
| K964694 | ELECSYS LH ASSAY | Boehringer Mannheim Corp. | Jan 24, 1997 | SESE |
| K964925 | SEALITE SCIENCES, INC. AQUALITE LH | Sealite Sciences, Inc. | Jan 22, 1997 | SESE |
| K963693 | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST | Princeton BioMeditech Corp. | Nov 29, 1996 | SESE |
Top Applicants
- Diagnostic Products Corp. — 5 clearances
- Amersham Corp. — 4 clearances
- Leeco Diagnostics, Inc. — 4 clearances
- Monoclonal Antibodies, Inc. — 4 clearances
- Nichols Institute Diagnostics — 4 clearances
