RUBENOSTICON— 510(k) K780063

Substantially Equivalent

Organon, Inc.

FDA 510(k) clearance K780063 for RUBENOSTICON, Substantially Equivalent on 1978-01-20. Applicant: Organon, Inc.. Device class: 2.

Clearance details

Applicant: Organon, Inc.
Product code: Code GOK
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1978-01-12
Decision date: 1978-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GOK

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K792635 — ANTIBODY TO RUBELLA VIRUS1980-03-19
K792133 — RUBELISA TEST KIT1980-01-11
K790122 — RUBANON1979-02-15

More clearances from Organon, Inc.

K950861 — RECONSTITUTION ACCESSOREIS1995-05-26
K853388 — MONOSTICON UNI-DOT1985-08-22
K842314 — DUOCLON COLOR-CEPT1984-08-24
K841525 — OREIA II B-HCG PREGNANCY TEST KIT1984-06-05
K841602 — ACCURATE BETA 30 PREGNANCY TEST KIT1984-05-22

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