Tcpi, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K981363ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TESTDecember 22, 1998
K972960HEALTH CHECK URI-TEST PROTEIN IN URINEOctober 7, 1998
K981197ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TESTJune 16, 1998
K980776ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TESTApril 29, 1998
K951853ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)August 20, 1996
K954968HEALTH CHECK URI-TEST GLUCOSE IN URINE TESTJuly 26, 1996
K954685URITEST - NITRITE IN URINE TESTJuly 22, 1996
K955353ONE STEP PREGNANCY HCG SERUN DILUENT REAGENTMarch 19, 1996
K952096ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE)August 17, 1995
K951892ONE STEP URINE DRUG OF ABUSE COCAINE TESTAugust 17, 1995
K941765HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USEOctober 20, 1994
K935134ONE STEP LH TESTJanuary 11, 1994
K934830HCG PREGNANCY ONE STEP TEST STRIPDecember 2, 1993
K923123HCG PREGNANCY ONE STEP TEST STRIPSeptember 9, 1992