Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Armkel, LLC — Predicate Candidate Screening

68 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

67 daysmedian FDA review time

186 days90th percentile

68clearances measured

K-number	Device	Applicant	Decided	Review days
K040866	FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST	Armkel, LLC	2004-10-19	200
K030258	FIRST RESPONSE PREGNANCY TEST	Armkel, LLC	2003-02-25	32
K023405	TROJAN MINT TINGLE BRAND LATEX CONDOMS	Armkel, LLC	2002-12-16	67
K013433	TROJAN PASSION BERRY GEL	Armkel, LLC	2002-03-05	140
K013614	TROJAN CRYSTAL CLEAR LIQUID	Armkel, LLC	2002-02-01	88
K001212	TROJAN EXTRA LARGE LATEX CONDOM	Armkel, LLC	2000-05-09	25
K000748	TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT	Armkel, LLC	2000-04-06	29
K992232	FIRST RESPONSE 1-STEP PREGNANCY	Armkel, LLC	1999-12-21	172
K973352	BRAND NAME *1-STEP PREGNANCY	Armkel, LLC	1997-10-27	52
K973310	TBD* ONE-STEP OVULATION PREDICTOR TEST	Armkel, LLC	1997-10-27	54
K963318	LEGIONELLA IGG/IGM ELISA TEST SYSTEM	Armkel, LLC	1997-03-03	192
K962558	CHLAMYDIA IGG ELISA TEST SYSTEM	Armkel, LLC	1997-02-24	238
K963645	HERPES GROUP IGG ELISA TEST SYSTEM	Armkel, LLC	1997-02-04	145
K961221	PYLORI IGG ELISA TEST SYSTEM	Armkel, LLC	1996-07-30	132
K962183	BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST	Armkel, LLC	1996-07-10	34
K961712	TBD AT-HOME PREGNANCY TEST	Armkel, LLC	1996-05-31	29
K953581	FIRST RESPONSE OVULATION PREDICTOR TEST	Armkel, LLC	1995-10-03	63
K914304	FIRST RESPONSE(R) ONE-STEP	Armkel, LLC	1991-10-17	22
K902305	TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.	Armkel, LLC	1991-03-29	311
K904000	TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR	Armkel, LLC	1991-02-19	174
K896875	POSITIVE AND NEGATIVE HCG SERUM CONTROLS	Armkel, LLC	1990-02-26	80
K900625	MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET	Armkel, LLC	1990-02-26	18
K895640	MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT	Armkel, LLC	1990-01-23	126
K894181	POSITIVE AND NEGATIVE HCG URINE CONTROLS	Armkel, LLC	1989-08-31	76
K890863	TROJAN FOR WOMEN	Armkel, LLC	1989-04-04	42
K885004	BACTIGEN(R) N. MENINGITIDIS	Armkel, LLC	1989-02-07	68
K885003	BACTIGEN(R) GROUP B STREPTOCOCCUS TEST	Armkel, LLC	1989-02-07	68
K884967	BACTIGEN(R) H. INFLUENZAE TYPE B	Armkel, LLC	1989-02-07	69
K884966	BACTIGEN(R) S. PNEUMONIAE	Armkel, LLC	1989-02-07	69
K884965	BACTIGEN(R) MENINGITIDIS PANEL	Armkel, LLC	1989-02-07	69
K883709	MODIFICATION OF MONO-PLUS(TM)	Armkel, LLC	1988-12-20	112
K871426	VIROGEN HSV ANTIBODY TEST	Armkel, LLC	1987-10-15	189
K871241	ANSWER OVULATION TEST KIT	Armkel, LLC	1987-10-02	189
K872114	BACTIGEN GROUP B STREPTOCOCCUS-CS TEST	Armkel, LLC	1987-08-27	87
K870813	BACTIGEN SALMONELLA-SHIGELLA TEST	Armkel, LLC	1987-04-22	50
K863198	PREGNASLIDE	Armkel, LLC	1986-09-29	41
K862008	MONO-LATEX (TM) SLIDE TEST	Armkel, LLC	1986-07-03	37
K860090	ANSWER PLUS AT HOME PREGNANCY TEST	Armkel, LLC	1986-04-11	91
K854430	RIGIDENT CREAM	Armkel, LLC	1986-03-04	119
K853399	VIROGEN ROTATEST SLIDE TEST	Armkel, LLC	1985-11-12	92
K852928	VIROGEN HERPES SLIDE TEST	Armkel, LLC	1985-10-17	100
K852274	ANSWER	Armkel, LLC	1985-06-28	30
K850772	BACTIGEN GROUP B STREPTOCOCCUS TEST	Armkel, LLC	1985-05-29	93
K844436	VIROGEN RUBELLA MICROTITER TEST	Armkel, LLC	1985-05-21	186
K844435	VIROGEN RUBELLA SLIDE TEST	Armkel, LLC	1985-05-20	185
K850992	PREGNA-ZYME	Armkel, LLC	1985-05-01	51
K843238	ANSWER ONE-DAY	Armkel, LLC	1984-09-14	23
K841907	BACTIGEN - N.MENNINIGITIDIS TEST	Armkel, LLC	1984-07-06	59
K831887	BACTIGEN S. PNEUMONIAE	Armkel, LLC	1983-09-26	105
K831775	UCG-BETA SLIDE MONOCLONAL	Armkel, LLC	1983-08-11	70

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda