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

41 results for "Organon, Inc."
1–24 of 41
Search insights Median review: 30d Cleared: 100% Top manufacturer: Organon, Inc. Lead specialty: Chemistry
Cleared May 26, 1995
RECONSTITUTION ACCESSOREIS
K950861 · FPK
Organon, Inc.
General Hospital · 88d
Cleared Aug 22, 1985
MONOSTICON UNI-DOT
K853388 · KTN
Organon, Inc.
Immunology · 9d
Cleared Aug 24, 1984
DUOCLON COLOR-CEPT
K842314 · JHJ
Organon, Inc.
Chemistry · 73d
Cleared Jun 05, 1984
OREIA II B-HCG PREGNANCY TEST KIT
K841525 · JHI
Organon, Inc.
Chemistry · 54d
Cleared May 22, 1984
ACCURATE BETA 30 PREGNANCY TEST KIT
K841602 · LCX
Organon, Inc.
Chemistry · 34d
Cleared Apr 04, 1984
B-NEOCEPT 30
K840650 · JHJ
Organon, Inc.
Chemistry · 49d
Cleared Dec 08, 1983
OREIA II B-HCG, ENZYME INNUNOASSAY
K832801 · JHI
Organon, Inc.
Chemistry · 112d
Cleared Jun 08, 1983
NEO-PREGNOSTICON DUOCLON TUBE TEST
K831339 · JHJ
Organon, Inc.
Immunology · 44d
Cleared Jun 02, 1983
DUOCLON SLIDE TEST
K831109 · JHI
Organon, Inc.
Immunology · 58d
Cleared Jan 07, 1983
BETA FFIRM TEST
K823682 · JHJ
Organon, Inc.
Chemistry · 31d
Cleared Nov 06, 1981
ACCURATE BETA
K812967 · JHJ
Organon, Inc.
Chemistry · 15d
Cleared Sep 01, 1981
B-NEOCEPT
K812334 · JHJ
Organon, Inc.
Chemistry · 14d
Cleared Aug 31, 1981
ACCURATE I
K812261 · JHJ
Organon, Inc.
Chemistry · 19d
Cleared Aug 03, 1981
OREIA II, B-HCG
K811940 · JHJ
Organon, Inc.
Chemistry · 28d
Cleared Jul 27, 1981
NEOCEPT
K811941 · JHJ
Organon, Inc.
Chemistry · 21d
Cleared Dec 19, 1980
RAPI-DOT
K802974 · JHJ
Organon, Inc.
Chemistry · 28d
Cleared Dec 11, 1980
STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.
K802634 · JOJ
Organon, Inc.
General Hospital · 50d
Cleared Dec 10, 1980
OREIA-Q-TY, ENZYME IMMUNOASSAY
K802693 · KLI
Organon, Inc.
Chemistry · 41d
Cleared Oct 31, 1980
OREAI-Q-TU TEST
K802464 · KHQ
Organon, Inc.
Chemistry · 22d
Cleared Oct 10, 1980
OREIA-Q-DIG
K802358 · KXT
Organon, Inc.
Toxicology · 14d
Cleared Jun 20, 1980
STREPTO-SEC TM
K801159 · GTZ
Organon, Inc.
Microbiology · 40d
Cleared Oct 30, 1979
OREIA-TU THYROID UPTAKER RATIO ASSAY
K791172
Organon, Inc.
Chemistry · 127d
Cleared Oct 01, 1979
QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)
K791723 · JJT
Organon, Inc.
Chemistry · 32d
Cleared Jun 15, 1979
PREGNOSTICON PREGNANCY TEST KIT
K790734 · JHJ
Organon, Inc.
Chemistry · 60d