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FDA 510(k)

MONODEX

K-Number: K894793 · 1989-08-21

ApplicantCenogenics Corp.
Decision Date1989-08-21
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MONODEX is the device name listed in this FDA 510(k) record. The listed applicant is Cenogenics Corp.. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K894793. 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 MONODEX?

MONODEX is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Cenogenics Corp.. The 510(k) number is K894793.

When did MONODEX receive FDA 510(k) clearance?

MONODEX received FDA 510(k) clearance on 1989-08-21, under 510(k) number K894793.

Who is the listed applicant for MONODEX?

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

What is the FDA product code for MONODEX?

The FDA product code for MONODEX is KTN.

Related Clinical Trials

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.

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Other records listing Cenogenics Corp. 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.

K042641CHEMVIEW-10K030533ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TESTK992397ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTEK843680URI-VAL

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

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

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