Armkel, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
68
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTOctober 19, 2004
K030258FIRST RESPONSE PREGNANCY TESTFebruary 25, 2003
K023405TROJAN MINT TINGLE BRAND LATEX CONDOMSDecember 16, 2002
K013433TROJAN PASSION BERRY GELMarch 5, 2002
K013614TROJAN CRYSTAL CLEAR LIQUIDFebruary 1, 2002
K001212TROJAN EXTRA LARGE LATEX CONDOMMay 9, 2000
K000748TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANTApril 6, 2000
K992232FIRST RESPONSE 1-STEP PREGNANCYDecember 21, 1999
K973310TBD* ONE-STEP OVULATION PREDICTOR TESTOctober 27, 1997
K973352BRAND NAME *1-STEP PREGNANCYOctober 27, 1997
K963318LEGIONELLA IGG/IGM ELISA TEST SYSTEMMarch 3, 1997
K962558CHLAMYDIA IGG ELISA TEST SYSTEMFebruary 24, 1997
K963645HERPES GROUP IGG ELISA TEST SYSTEMFebruary 4, 1997
K961221PYLORI IGG ELISA TEST SYSTEMJuly 30, 1996
K962183BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMESJuly 10, 1996
K961712TBD AT-HOME PREGNANCY TESTMay 31, 1996
K953581FIRST RESPONSE OVULATION PREDICTOR TESTOctober 3, 1995
K914304FIRST RESPONSE(R) ONE-STEPOctober 17, 1991
K902305TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.March 29, 1991
K904000TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBRFebruary 19, 1991