International Newtech Development, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K993850 | URINALYSIS REAGENT STRIPS (10 PARAMETERS) | January 3, 2000 |
| K974060 | MINISTRIP/ SERUM AND URINE COMBO HCG TEST | April 9, 1998 |
| K974059 | ONE STEP MIDSTREAM HCG PREGNANCY TEST | April 9, 1998 |
| K974009 | PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG | March 13, 1998 |
| K970176 | HCG CONTROLS | February 6, 1997 |
| K963133 | PS-UNIT CASSETTE/SERUM HCG | November 18, 1996 |
| K963132 | MINI STRIP/SERUM HCG | November 18, 1996 |
| K951705 | MINISTRIP HCG | October 3, 1995 |