Product code JHJ
- Device name
- Agglutination Method, Human Chorionic Gonadotropin
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1155
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972606 | PREGNACOL PREGNANCY TEST | Immunostics Inc., | 1997-08-29 |
| K921968 | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | Tech-Co, Inc. | 1996-06-28 |
| K935863 | SAS(TM) DIRECT MONOCLONAL HCG | Sa Scientific, Inc. | 1994-02-24 |
| K926112 | ACCUTEX BETA-HCG TEST | J.S. Medical Assoc. | 1993-07-28 |
| K930609 | SAS(TM) MONOCLONAL HCG-SLIDE | Sa Scientific, Inc. | 1993-03-29 |
| K920716 | DIRECT PREGNANCY TEST | Tech-Co, Inc. | 1992-03-24 |
| K910946 | CLEARVIEW HCG | Unipath , Ltd. | 1991-04-01 |
| K881435 | PREGNOSPIA II | Organon Teknika Corp. | 1988-05-27 |
| K880163 | PREGNANCY (HCG) CARD & LIQUID TEST | Ampcor, Inc. | 1988-05-17 |
| K880478 | PREGNANCY BETA-HCG CARD & LIQUID TEST | Ampcor, Inc. | 1988-04-28 |
| K880328 | HCG-NOSTICK | Organon Teknika Corp. | 1988-03-15 |
| K875262 | V-TREND BETA-HCG DRY-SPOT TEST | Texas Immunology, Inc. | 1988-02-02 |
| K874638 | V-TREND BETA-HCG TEST | Texas Immunology, Inc. | 1988-01-21 |
| K871294 | ACU-PREG-AL SLIDE TEST | Papibris Scientific, Inc. | 1987-05-12 |
| K863741 | IMMUNO-CEPT D (BETA-MONOCLONAL) | Immunostics Co., Inc. | 1986-11-13 |
| K861211 | MONO ACU-SLIDE TEST | Cal-Tech Diagnostics, Inc. | 1986-11-05 |
| K863198 | PREGNASLIDE | Armkel, LLC | 1986-09-29 |
| K861703 | LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) | Leeco Diagnostics, Inc. | 1986-07-29 |
| K862044 | DELFIA (TM) HCG KIT | Lkb Instruments, Inc. | 1986-07-11 |
| K861212 | DIRECT ACU-SLIDE TEST | Cal-Tech Diagnostics, Inc. | 1986-07-07 |
| K862083 | HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY | Hygeia Sciences | 1986-07-02 |
| K860945 | DIRECTACLONE CG SLIDE PREGNANCY TEST | Pacific Biotech, Inc. | 1986-05-02 |
| K854670 | TERUMO SENSIBEAD EIG HCG KIT | Terumo Medical Corp. | 1986-02-13 |
| K853247 | ACU-SLIDE-TEST | Cal-Tech Diagnostics, Inc. | 1985-09-04 |
| K852286 | DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST | Sero-Immuno Diagnostics, Inc. | 1985-07-09 |
| K852066 | PREGNANCY CARD TEST | Em Diagnostic Systems, Inc. | 1985-06-25 |
| K850604 | PRECO PREGNANCY RAPID CARD TEST, HEM #2028 | Preco, Inc. | 1985-04-08 |
| K844346 | FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES | Fisher Diagnostics | 1985-03-04 |
| K844914 | ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN | Abbott Laboratories | 1985-02-12 |
| K844347 | FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT | Fisher Diagnostics | 1985-01-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10722355001446 | Detector Cept-D Polyclonal | Immunostics Company, Inc | 2016-09-20 |
| 06438147009176 | DELFIA hCG kit | Wallac Oy | 2016-02-11 |
| 06438147009336 | AutoDELFIA hCG kit | Wallac Oy | 2016-02-11 |
| 06438147009343 | AutoDELFIA hCG kit | Wallac Oy | 2016-02-11 |