DUOCLON COLOR-CEPT— 510(k) K842314

Substantially Equivalent

Organon, Inc.

FDA 510(k) clearance K842314 for DUOCLON COLOR-CEPT, Substantially Equivalent on 1984-08-24. Applicant: Organon, Inc.. Device class: 2.

Clearance details

Applicant: Organon, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1984-06-12
Decision date: 1984-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHJ

K972606 — PREGNACOL PREGNANCY TEST1997-08-29
K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST1996-06-28
K935863 — SAS(TM) DIRECT MONOCLONAL HCG1994-02-24
K926112 — ACCUTEX BETA-HCG TEST1993-07-28
K930609 — SAS(TM) MONOCLONAL HCG-SLIDE1993-03-29

More clearances from Organon, Inc.

K950861 — RECONSTITUTION ACCESSOREIS1995-05-26
K853388 — MONOSTICON UNI-DOT1985-08-22
K841525 — OREIA II B-HCG PREGNANCY TEST KIT1984-06-05
K841602 — ACCURATE BETA 30 PREGNANCY TEST KIT1984-05-22
K840650 — B-NEOCEPT 301984-04-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.