Syntron Bioresearch, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 26
- Inspections
- 6
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K993491 | QUICKPAC II ONE STEP OPIATES TEST | October 29, 1999 |
| K993490 | QUICKSTRIP ONE STEP OPIATES TEST | October 29, 1999 |
| K992990 | QUICKPAC II ONE STEP COCAINE TEST | September 20, 1999 |
| K992748 | DRUGCHECK X MULTIDRUG SCREENING DEVICE | September 2, 1999 |
| K992207 | QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM | July 22, 1999 |
| K990325 | QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE | June 24, 1999 |
| K983113 | BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT | November 18, 1998 |
| K981292 | QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST | May 26, 1998 |
| K981019 | QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST | May 7, 1998 |
| K980349 | QUICKPAC II ONE STEP BARBITURATE TEST | March 3, 1998 |
| K974712 | QUIKSTRIP ONE STEP BARBITURATE TEST | February 12, 1998 |
| K963654 | QUIKSTRIP ONESTEP MARIJUANA (THC) TEST | February 28, 1997 |
| K963341 | MIDSTREAM ONESTEP PREGNANCY HOME TEST | December 2, 1996 |
| K960117 | PLATFORM ONESTEP PREGNANCY HOME TEST | March 19, 1996 |
| K935475 | QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU | August 30, 1995 |
| K935554 | QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY | August 30, 1995 |
| K951538 | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT | July 11, 1995 |
| K945951 | QUIKPAC II, ONE STEP HCG COMBO KIT | February 8, 1995 |
| K930488 | BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST | April 6, 1993 |
| K924007 | QUIKPAC STREP A TEST | April 6, 1993 |