Wyntek Diagnostics, Inc.

FDA Regulatory Profile

Wyntek Diagnostics, Inc. appears in FDA public data with 0 recalls, 12 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on January 18, 2000.

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K992658OSOM ULTRA STREP A TEST, MODEL 147January 18, 2000
K990576OSOM CARD PREGNANCY TEST, MODEL 103March 9, 1999
K990578OSOM CARD II HCG-URINE TEST, MODEL 102March 9, 1999
K974159OSOM HCG-URINE TEST MODEL 101December 24, 1997
K973879OSOM CARD HCG-URINE TESTNovember 4, 1997
K972231OSOM MONO TEST 143August 26, 1997
K965227OSOM CLASSIC HCG-URINE TEST (115)February 4, 1997
K965184PERFECTA PREGNANCY TESTFebruary 4, 1997
K961423OSOM STREP A TESTOctober 11, 1996
K955141OSOM HCG COMBO TESTDecember 6, 1995
K954178OSOM PREGNANCY TESTOctober 23, 1995
K953383WYNTEK OSOM HCG-URINE TESTAugust 29, 1995