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FDA 510(k)

MONOSTICON UNI-DOT

K-Number: K853388 · 1985-08-22

ApplicantOrganon, Inc.
Decision Date1985-08-22
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MONOSTICON UNI-DOT is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1985-08-22 under 510(k) number K853388. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOSTICON UNI-DOT?

MONOSTICON UNI-DOT is a medical device that received FDA 510(k) clearance on 1985-08-22. The listed applicant is Organon, Inc.. The 510(k) number is K853388.

When did MONOSTICON UNI-DOT receive FDA 510(k) clearance?

MONOSTICON UNI-DOT received FDA 510(k) clearance on 1985-08-22, under 510(k) number K853388.

Who is the listed applicant for MONOSTICON UNI-DOT?

The FDA 510(k) record lists Organon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOSTICON UNI-DOT?

The FDA product code for MONOSTICON UNI-DOT is KTN.

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Other records listing Organon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950861RECONSTITUTION ACCESSOREISK842314DUOCLON COLOR-CEPTK841525OREIA II B-HCG PREGNANCY TEST KITK841602ACCURATE BETA 30 PREGNANCY TEST KITK840650B-NEOCEPT 30K832801OREIA II B-HCG, ENZYME INNUNOASSAY

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Related Devices (Code: KTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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