JHJ — Agglutination Method, Human Chorionic Gonadotropin Class II
FDA product code JHJ covers "Agglutination Method, Human Chorionic Gonadotropin", a Class II medical device regulated under 21 CFR 862.1155. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |