JHI — Visual, Pregnancy Hcg, Prescription Use Class II
FDA product code JHI covers "Visual, Pregnancy Hcg, Prescription Use", 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
- JHI
- 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 |
|---|---|---|---|
| K241919 | innovita (tangshan) biological technology co | Innovita HCG Pregnancy Rapid Combo Test | August 2, 2024 |
| K203272 | hangzhou alltest biotech co | Alltest Pregnancy Rapid Combo Test Cassette | January 31, 2022 |
| K172322 | siemens healthcare diagnostics | Atellica IM Total hCG (ThCG) | March 29, 2018 |
| K172257 | true diagnostics | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Resu | December 22, 2017 |
| K152768 | assure tech. co | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregn | February 24, 2016 |
| K130456 | james nguyen | WUNDER PREGNANCY TEST | April 8, 2014 |
| K132834 | polymed therapeutics | FASTEP S10 HCG SERUM/URINE COMBO TEST | January 9, 2014 |
| K131166 | quidel | SOFIA(R) HCG FIA | August 2, 2013 |
| K123844 | chemtron biotech | CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND H | May 30, 2013 |
| K112101 | polymed therapeutics | FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS | July 17, 2012 |
| K112315 | newscen coast bio-pharmaceutical co | HOME PREGNANCY TEST | April 23, 2012 |
| K102175 | quidel corporation | RAPIDVUE HCG TEST | August 25, 2010 |
| K072264 | qualigen | FASTPACK HCG IMMUNOASSAY | December 6, 2007 |
| K070921 | applied dna technologies | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG | June 29, 2007 |
| K071030 | applied dna technologies | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC A | June 29, 2007 |
| K061257 | ameritek usa | DBEST HCG PANEL TEST KIT | May 4, 2007 |
| K062361 | innovacon | INNOVACON HCG UKTRA TEST DEVICE | October 23, 2006 |
| K050955 | princeton biomeditech | LIFESIGN DXPRESS, MODEL LSR2000 | January 23, 2006 |
| K052694 | ind diagnostic | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | December 16, 2005 |
| K051841 | w.h.p.m | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST | August 22, 2005 |