JHI — Visual, Pregnancy Hcg, Prescription Use Class II
FDA Device Classification
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 |
| K071030 | applied dna technologies | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC A | June 29, 2007 |
| K070921 | applied dna technologies | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG | 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 |