Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

68 results for "Armkel, LLC"

1–24 of 68

Search insights Median review: 63d Cleared: 100% Top manufacturer: Armkel, LLC Lead specialty: Chemistry

Cleared Oct 19, 2004

FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST

Chemistry · 200d

Cleared Feb 25, 2003

FIRST RESPONSE PREGNANCY TEST

Chemistry · 32d

Cleared Dec 16, 2002

TROJAN MINT TINGLE BRAND LATEX CONDOMS

Obstetrics & Gynecology · 67d

Cleared Mar 05, 2002

TROJAN PASSION BERRY GEL

Obstetrics & Gynecology · 140d

Cleared Feb 01, 2002

TROJAN CRYSTAL CLEAR LIQUID

Obstetrics & Gynecology · 88d

Cleared May 09, 2000

TROJAN EXTRA LARGE LATEX CONDOM

Obstetrics & Gynecology · 25d

Cleared Apr 06, 2000

TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT

Obstetrics & Gynecology · 29d

Cleared Dec 21, 1999

FIRST RESPONSE 1-STEP PREGNANCY

Chemistry · 172d

Cleared Oct 27, 1997

BRAND NAME *1-STEP PREGNANCY

Chemistry · 52d

Cleared Oct 27, 1997

TBD* ONE-STEP OVULATION PREDICTOR TEST

Chemistry · 54d

Cleared Mar 03, 1997

LEGIONELLA IGG/IGM ELISA TEST SYSTEM

Microbiology · 192d

Cleared Feb 24, 1997

CHLAMYDIA IGG ELISA TEST SYSTEM

Microbiology · 238d

Cleared Feb 04, 1997

HERPES GROUP IGG ELISA TEST SYSTEM

Microbiology · 145d

Cleared Jul 30, 1996

PYLORI IGG ELISA TEST SYSTEM

Microbiology · 132d

Cleared Jul 10, 1996

BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE,...

Chemistry · 34d

Cleared May 31, 1996

TBD AT-HOME PREGNANCY TEST

Chemistry · 29d

Cleared Oct 03, 1995

FIRST RESPONSE OVULATION PREDICTOR TEST

Chemistry · 63d

Cleared Oct 17, 1991

FIRST RESPONSE(R) ONE-STEP

Chemistry · 22d

Cleared Mar 29, 1991

TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.

Obstetrics & Gynecology · 311d

Cleared Feb 19, 1991

TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR

Obstetrics & Gynecology · 174d

Cleared Feb 26, 1990

MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET

Immunology · 18d

Cleared Feb 26, 1990

POSITIVE AND NEGATIVE HCG SERUM CONTROLS

Chemistry · 80d

Cleared Jan 23, 1990

MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT

Obstetrics & Gynecology · 126d

Cleared Aug 31, 1989

POSITIVE AND NEGATIVE HCG URINE CONTROLS

Chemistry · 76d