JHJ · Agglutination Method, Human Chorionic Gonadotropin
Clinical Chemistry · 21 CFR 862.1155 · Class 2
Overview
| Product Code | JHJ |
|---|---|
| Device Name | Agglutination Method, Human Chorionic Gonadotropin |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.
Classification Rationale
For early detection of pregnancy: Class II. For any uses other than early detection of pregnancy: Class III.
Recent Cleared Devices (20 of 96)
Showing 20 most recent of 96 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972606 | PREGNACOL PREGNANCY TEST | Immunostics Inc., | Aug 29, 1997 | SESE |
| K921968 | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | Tech-Co, Inc. | Jun 28, 1996 | SESE |
| K935863 | SAS(TM) DIRECT MONOCLONAL HCG | Sa Scientific, Inc. | Feb 24, 1994 | SESE |
| K926112 | ACCUTEX BETA-HCG TEST | J.S. Medical Assoc. | Jul 28, 1993 | SESE |
| K930609 | SAS(TM) MONOCLONAL HCG-SLIDE | Sa Scientific, Inc. | Mar 29, 1993 | SESE |
| K920716 | DIRECT PREGNANCY TEST | Tech-Co, Inc. | Mar 24, 1992 | SESE |
| K910946 | CLEARVIEW HCG | Unipath , Ltd. | Apr 1, 1991 | SESE |
| K881435 | PREGNOSPIA II | Organon Teknika Corp. | May 27, 1988 | SESE |
| K880163 | PREGNANCY (HCG) CARD & LIQUID TEST | Ampcor, Inc. | May 17, 1988 | SESE |
| K880478 | PREGNANCY BETA-HCG CARD & LIQUID TEST | Ampcor, Inc. | Apr 28, 1988 | SESE |
| K880328 | HCG-NOSTICK | Organon Teknika Corp. | Mar 15, 1988 | SESE |
| K875262 | V-TREND BETA-HCG DRY-SPOT TEST | Texas Immunology, Inc. | Feb 2, 1988 | SESE |
| K874638 | V-TREND BETA-HCG TEST | Texas Immunology, Inc. | Jan 21, 1988 | SESE |
| K871294 | ACU-PREG-AL SLIDE TEST | Papibris Scientific, Inc. | May 12, 1987 | SESE |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Immunostics Co., Inc. | Nov 13, 1986 | SESE |
| K861211 | MONO ACU-SLIDE TEST | Cal-Tech Diagnostics, Inc. | Nov 5, 1986 | SESE |
| K863198 | PREGNASLIDE | Armkel, LLC | Sep 29, 1986 | SESE |
| K861703 | LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) | Leeco Diagnostics, Inc. | Jul 29, 1986 | SESE |
| K862044 | DELFIA (TM) HCG KIT | Lkb Instruments, Inc. | Jul 11, 1986 | SESE |
| K861212 | DIRECT ACU-SLIDE TEST | Cal-Tech Diagnostics, Inc. | Jul 7, 1986 | SESE |
Top Applicants
- Organon, Inc. — 11 clearances
- Armkel, LLC — 6 clearances
- Stanbio Laboratory — 4 clearances
- Texas Immunology, Inc. — 3 clearances
- Monoclonal Antibodies, Inc. — 3 clearances
