JHJ — Agglutination Method, Human Chorionic Gonadotropin Class II
FDA Device Classification
Classification Details
- Product Code
- JHJ
- Device Class
- Class II
- Regulation Number
- 862.1155
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K972606 | immunostics inc | PREGNACOL PREGNANCY TEST | August 29, 1997 |
| K921968 | tech-co | IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST | June 28, 1996 |
| K935863 | sa scientific | SAS(TM) DIRECT MONOCLONAL HCG | February 24, 1994 |
| K926112 | j.s. medical assoc | ACCUTEX BETA-HCG TEST | July 28, 1993 |
| K930609 | sa scientific | SAS(TM) MONOCLONAL HCG-SLIDE | March 29, 1993 |
| K920716 | tech-co | DIRECT PREGNANCY TEST | March 24, 1992 |
| K910946 | unipath | CLEARVIEW HCG | April 1, 1991 |
| K881435 | organon teknika | PREGNOSPIA II | May 27, 1988 |
| K880163 | ampcor | PREGNANCY (HCG) CARD & LIQUID TEST | May 17, 1988 |
| K880478 | ampcor | PREGNANCY BETA-HCG CARD & LIQUID TEST | April 28, 1988 |
| K880328 | organon teknika | HCG-NOSTICK | March 15, 1988 |
| K875262 | texas immunology | V-TREND BETA-HCG DRY-SPOT TEST | February 2, 1988 |
| K874638 | texas immunology | V-TREND BETA-HCG TEST | January 21, 1988 |
| K871294 | papibris scientific | ACU-PREG-AL SLIDE TEST | May 12, 1987 |
| K863741 | immunostics co | IMMUNO-CEPT D (BETA-MONOCLONAL) | November 13, 1986 |
| K861211 | cal-tech diagnostics | MONO ACU-SLIDE TEST | November 5, 1986 |
| K863198 | armkel | PREGNASLIDE | September 29, 1986 |
| K861703 | leeco diagnostics | LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) | July 29, 1986 |
| K862044 | lkb instruments | DELFIA (TM) HCG KIT | July 11, 1986 |
| K861212 | cal-tech diagnostics | DIRECT ACU-SLIDE TEST | July 7, 1986 |