Medical Device Manufacturer · US , Mchenry , IL

Armkel, LLC

68 submissions · 68 cleared · Since 1979
68
Total
68
Cleared
0
Denied

Armkel, LLC — FDA 510(k) Submissions

Armkel, LLC has submitted 68 FDA 510(k) premarket notifications since 1979, of which 68 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Kit, Test, Pregnancy, Hcg, Over The Counter, Condom, Agglutination Method, Human Chorionic Gonadotropin, Radioimmunoassay, Luteinizing Hormone, Single (specified) Analyte Controls (assayed And Unassayed) . Use the specialty filter in the sidebar to narrow results.

68 devices
1–25 of 68
FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST
K040866 · LCX Kit, Test, Pregnancy,... · Chemistry
Oct 2004 200d
FIRST RESPONSE PREGNANCY TEST
K030258 · LCX Kit, Test, Pregnancy,... · Chemistry
Feb 2003 32d
TROJAN MINT TINGLE BRAND LATEX CONDOMS
K023405 · HIS Condom · Obstetrics & Gynecology
Dec 2002 67d
TROJAN PASSION BERRY GEL
K013433 · NUC Lubricant, Personal · Obstetrics & Gynecology
Mar 2002 140d
TROJAN CRYSTAL CLEAR LIQUID
K013614 · NUC Lubricant, Personal · Obstetrics & Gynecology
Feb 2002 88d
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · HIS Condom · Obstetrics & Gynecology
May 2000 25d
TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
K000748 · HIS Condom · Obstetrics & Gynecology
Apr 2000 29d
FIRST RESPONSE 1-STEP PREGNANCY
K992232 · LCX Kit, Test, Pregnancy,... · Chemistry
Dec 1999 172d
TBD* ONE-STEP OVULATION PREDICTOR TEST
K973310 · CEP Radioimmunoassay,... · Chemistry
Oct 1997 54d
BRAND NAME *1-STEP PREGNANCY
K973352 · LCX Kit, Test, Pregnancy,... · Chemistry
Oct 1997 52d
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
K963318 · LHL Reagents, Antibody,... · Microbiology
Mar 1997 192d
CHLAMYDIA IGG ELISA TEST SYSTEM
K962558 · LJC Enzyme Linked... · Microbiology
Feb 1997 238d
HERPES GROUP IGG ELISA TEST SYSTEM
K963645 · LGC Enzyme Linked... · Microbiology
Feb 1997 145d
PYLORI IGG ELISA TEST SYSTEM
K961221 · LYR Helicobacter Pylori · Microbiology
Jul 1996 132d
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
K962183 · LCX Kit, Test, Pregnancy,... · Chemistry
Jul 1996 34d
TBD AT-HOME PREGNANCY TEST
K961712 · LCX Kit, Test, Pregnancy,... · Chemistry
May 1996 29d
FIRST RESPONSE OVULATION PREDICTOR TEST
K953581 · CEP Radioimmunoassay,... · Chemistry
Oct 1995 63d
FIRST RESPONSE(R) ONE-STEP
K914304 · LCX Kit, Test, Pregnancy,... · Chemistry
Oct 1991 22d
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
K902305 · HIS Condom · Obstetrics & Gynecology
Mar 1991 311d
TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR
K904000 · HIS Condom · Obstetrics & Gynecology
Feb 1991 174d
POSITIVE AND NEGATIVE HCG SERUM CONTROLS
K896875 · JJX Single (specified)... · Chemistry
Feb 1990 80d
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
K900625 · KTN System, Test, Infectious... · Immunology
Feb 1990 18d
MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
K895640 · HIS Condom · Obstetrics & Gynecology
Jan 1990 126d
POSITIVE AND NEGATIVE HCG URINE CONTROLS
K894181 · JJX Single (specified)... · Chemistry
Aug 1989 76d
TROJAN FOR WOMEN
K890863 · HIS Condom · Obstetrics & Gynecology
Apr 1989 42d
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