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"
25–48 of 68
Search insights Median review: 63d Cleared: 100% Top manufacturer: Armkel, LLC Lead specialty: Chemistry
Cleared Apr 04, 1989
TROJAN FOR WOMEN
K890863 · HIS
Armkel, LLC
Obstetrics & Gynecology · 42d
Cleared Feb 07, 1989
BACTIGEN(R) N. MENINGITIDIS
K885004 · GTJ
Armkel, LLC
Microbiology · 68d
Cleared Feb 07, 1989
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
K885003 · GTZ
Armkel, LLC
Microbiology · 68d
Cleared Feb 07, 1989
BACTIGEN(R) H. INFLUENZAE TYPE B
K884967 · GRP
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) S. PNEUMONIAE
K884966 · GWC
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) MENINGITIDIS PANEL
K884965 · GWC
Armkel, LLC
Microbiology · 69d
Cleared Dec 20, 1988
MODIFICATION OF MONO-PLUS(TM)
K883709 · KTN
Armkel, LLC
Immunology · 112d
Cleared Oct 15, 1987
VIROGEN HSV ANTIBODY TEST
K871426 · GQO
Armkel, LLC
Microbiology · 189d
Cleared Oct 02, 1987
ANSWER OVULATION TEST KIT
K871241 · CEP
Armkel, LLC
Chemistry · 189d
Cleared Aug 27, 1987
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
K872114 · GTZ
Armkel, LLC
Microbiology · 87d
Cleared Apr 22, 1987
BACTIGEN SALMONELLA-SHIGELLA TEST
K870813 · GRM
Armkel, LLC
Microbiology · 50d
Cleared Sep 29, 1986
PREGNASLIDE
K863198 · JHJ
Armkel, LLC
Chemistry · 41d
Cleared Jul 03, 1986
MONO-LATEX (TM) SLIDE TEST
K862008 · KTN
Armkel, LLC
Immunology · 37d
Cleared Apr 11, 1986
ANSWER PLUS AT HOME PREGNANCY TEST
K860090 · LCX
Armkel, LLC
Chemistry · 91d
Cleared Mar 04, 1986
RIGIDENT CREAM
K854430 · KOT
Armkel, LLC
Dental · 119d
Cleared Nov 12, 1985
VIROGEN ROTATEST SLIDE TEST
K853399 · LIQ
Armkel, LLC
Microbiology · 92d
Cleared Oct 17, 1985
VIROGEN HERPES SLIDE TEST
K852928 · GQO
Armkel, LLC
Microbiology · 100d
Cleared Jun 28, 1985
ANSWER
K852274 · LCX
Armkel, LLC
Chemistry · 30d
Cleared May 29, 1985
BACTIGEN GROUP B STREPTOCOCCUS TEST
K850772 · GTZ
Armkel, LLC
Microbiology · 93d
Cleared May 21, 1985
VIROGEN RUBELLA MICROTITER TEST
K844436 · LQN
Armkel, LLC
Microbiology · 186d
Cleared May 20, 1985
VIROGEN RUBELLA SLIDE TEST
K844435 · LQN
Armkel, LLC
Microbiology · 185d
Cleared May 01, 1985
PREGNA-ZYME
K850992 · JHI
Armkel, LLC
Chemistry · 51d
Cleared Sep 14, 1984
ANSWER ONE-DAY
K843238 · LCX
Armkel, LLC
Chemistry · 23d
Cleared Jul 06, 1984
BACTIGEN - N.MENNINIGITIDIS TEST
K841907 · GTJ
Armkel, LLC
Microbiology · 59d