ClearanceBrief
Company ยท US

Organon, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2026. Name variants (Inc, Corp, punctuation) are merged.

42510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
JHJAgglutination Method, Human Chorionic Gonadotropin11
JHIVisual, Pregnancy Hcg, Prescription Use4
DHRSystem, Test, Rheumatoid Factor2
GIMTubes, Vacuum Sample, With Anticoagulant2
GOKAntisera, Hai (Including Hai Control), Rubella2
KTNSystem, Test, Infectious Mononucleosis2
KXTEnzyme Immunoassay, Digoxin2
LCXKit, Test, Pregnancy, Hcg, Over The Counter2
CDXRadioimmunoassay, Total Thyroxine1
DEWIgg, Antigen, Antiserum, Control1
FPKTubing, Fluid Delivery1
FQZThermometer, Clinical Color Change1
GTZAntisera, All Groups, Streptococcus Spp.1
JJTEnzyme Controls (Assayed And Unassayed)1
JMMColumn Chromatography & Color Development, Hydroxyproline1
JOJIndicator, Physical/Chemical Sterilization Process1
JQXNephelometer, For Clinical Use1
KHQRadioassay, Triiodothyronine Uptake1
KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine1
OQYIntrauterine Tamponade Balloon1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 15, 2026K253642Jada System (Jada-2002)
Organon, LLC
OQY
May 26, 1995K950861RECONSTITUTION ACCESSOREIS
Organon, Inc.
FPK
Aug 22, 1985K853388MONOSTICON UNI-DOT
Organon, Inc.
KTN
Aug 24, 1984K842314DUOCLON COLOR-CEPT
Organon, Inc.
JHJ
Jun 5, 1984K841525OREIA II B-HCG PREGNANCY TEST KIT
Organon, Inc.
JHI
May 22, 1984K841602ACCURATE BETA 30 PREGNANCY TEST KIT
Organon, Inc.
LCX
Apr 4, 1984K840650B-NEOCEPT 30
Organon, Inc.
JHJ
Dec 8, 1983K832801OREIA II B-HCG, ENZYME INNUNOASSAY
Organon, Inc.
JHI
Jun 8, 1983K831339NEO-PREGNOSTICON DUOCLON TUBE TEST
Organon, Inc.
JHJ
Jun 2, 1983K831109DUOCLON SLIDE TEST
Organon, Inc.
JHI
Jan 7, 1983K823682BETA FFIRM TEST
Organon, Inc.
JHJ
Nov 6, 1981K812967ACCURATE BETA
Organon, Inc.
JHJ
Sep 1, 1981K812334B-NEOCEPT
Organon, Inc.
JHJ
Aug 31, 1981K812261ACCURATE I
Organon, Inc.
JHJ
Aug 3, 1981K811940OREIA II, B-HCG
Organon, Inc.
JHJ
Jul 27, 1981K811941NEOCEPT
Organon, Inc.
JHJ
Dec 19, 1980K802974RAPI-DOT
Organon, Inc.
JHJ
Dec 11, 1980K802634STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.
Organon, Inc.
JOJ
Dec 10, 1980K802693OREIA-Q-TY, ENZYME IMMUNOASSAY
Organon, Inc.
KLI
Oct 31, 1980K802464OREAI-Q-TU TEST
Organon, Inc.
KHQ
Oct 10, 1980K802358OREIA-Q-DIG
Organon, Inc.
KXT
Jun 20, 1980K801159STREPTO-SEC TM
Organon, Inc.
GTZ
Oct 30, 1979K791172OREIA-TU THYROID UPTAKER RATIO ASSAY
Organon, Inc.
Oct 1, 1979K791723QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)
Organon, Inc.
JJT
Jun 15, 1979K790734PREGNOSTICON PREGNANCY TEST KIT
Organon, Inc.
JHJ
Apr 10, 1979K790521OREIA - DIGOXIN
Organon, Inc.
KXT
Feb 15, 1979K790122RUBANON
Organon, Inc.
GOK
Oct 11, 1978K781554RAD-291
Organon, Inc.
JQX
Apr 12, 1978K780308OREIA-T4
Organon, Inc.
CDX
Feb 27, 1978K780240PREDICTOR
Organon, Inc.
LCX
Jan 20, 1978K780063RUBENOSTICON
Organon, Inc.
GOK
Nov 23, 1977K772086QUANTROLS HCG
Organon, Inc.
JHI
Nov 2, 1977K771941QUANTROLS IM
Organon, Inc.
Nov 2, 1977K771940QUANTROLS RF
Organon, Inc.
DHR
Sep 2, 1977K771410RHEUMANOSTICON R
Organon, Inc.
DHR
Sep 2, 1977K770603HYPRONOSTICON TM
Organon, Inc.
JMM
Aug 22, 1977K771397MONOSTICON TEST
Organon, Inc.
KTN
Aug 4, 1977K771305LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
Organon, Inc.
GIM
Aug 4, 1977K771304LIQUAEMIB SODIUM PRESERVATIVE, ETC.
Organon, Inc.
GIM
Jun 27, 1977K771038THERMOMETER, SINGLE USE, STRIP, TEMPADOT
Organon, Inc.
FQZ
Jun 15, 1977K770605TUBES, HYDROLYSIS, CALIBRATED
Organon, Inc.
Apr 28, 1977K770597DASP TM ANTI-RABBIT
Organon, Inc.
DEW

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