Armkel, LLC

FDA 510(k) & PMA Approved Devices — 68 products

Total Devices68

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K040866	FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST	LCX	2004-10-19	View
510(k)	K030258	FIRST RESPONSE PREGNANCY TEST	LCX	2003-02-25	View
510(k)	K023405	TROJAN MINT TINGLE BRAND LATEX CONDOMS	HIS	2002-12-16	View
510(k)	K013433	TROJAN PASSION BERRY GEL	NUC	2002-03-05	View
510(k)	K013614	TROJAN CRYSTAL CLEAR LIQUID	NUC	2002-02-01	View
510(k)	K001212	TROJAN EXTRA LARGE LATEX CONDOM	HIS	2000-05-09	View
510(k)	K000748	TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT	HIS	2000-04-06	View
510(k)	K992232	FIRST RESPONSE 1-STEP PREGNANCY	LCX	1999-12-21	View
510(k)	K973352	BRAND NAME *1-STEP PREGNANCY	LCX	1997-10-27	View
510(k)	K973310	TBD* ONE-STEP OVULATION PREDICTOR TEST	CEP	1997-10-27	View
510(k)	K963318	LEGIONELLA IGG/IGM ELISA TEST SYSTEM	LHL	1997-03-03	View
510(k)	K962558	CHLAMYDIA IGG ELISA TEST SYSTEM	LJC	1997-02-24	View
510(k)	K963645	HERPES GROUP IGG ELISA TEST SYSTEM	LGC	1997-02-04	View
510(k)	K961221	PYLORI IGG ELISA TEST SYSTEM	LYR	1996-07-30	View
510(k)	K962183	BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES	LCX	1996-07-10	View
510(k)	K961712	TBD AT-HOME PREGNANCY TEST	LCX	1996-05-31	View
510(k)	K953581	FIRST RESPONSE OVULATION PREDICTOR TEST	CEP	1995-10-03	View
510(k)	K914304	FIRST RESPONSE(R) ONE-STEP	LCX	1991-10-17	View
510(k)	K902305	TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.	HIS	1991-03-29	View
510(k)	K904000	TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR	HIS	1991-02-19	View