Wyntek Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K992658 | OSOM ULTRA STREP A TEST, MODEL 147 | January 18, 2000 |
| K990576 | OSOM CARD PREGNANCY TEST, MODEL 103 | March 9, 1999 |
| K990578 | OSOM CARD II HCG-URINE TEST, MODEL 102 | March 9, 1999 |
| K974159 | OSOM HCG-URINE TEST MODEL 101 | December 24, 1997 |
| K973879 | OSOM CARD HCG-URINE TEST | November 4, 1997 |
| K972231 | OSOM MONO TEST 143 | August 26, 1997 |
| K965184 | PERFECTA PREGNANCY TEST | February 4, 1997 |
| K965227 | OSOM CLASSIC HCG-URINE TEST (115) | February 4, 1997 |
| K961423 | OSOM STREP A TEST | October 11, 1996 |
| K955141 | OSOM HCG COMBO TEST | December 6, 1995 |
| K954178 | OSOM PREGNANCY TEST | October 23, 1995 |
| K953383 | WYNTEK OSOM HCG-URINE TEST | August 29, 1995 |