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FDA 510(k)

DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST

K-Number: K893737 · 1989-06-16

ApplicantQuidel Corp.
Decision Date1989-06-16
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K893737. 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 DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST?

DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Quidel Corp.. The 510(k) number is K893737.

When did DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST receive FDA 510(k) clearance?

DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST received FDA 510(k) clearance on 1989-06-16, under 510(k) number K893737.

Who is the listed applicant for DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST?

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

What is the FDA product code for DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST?

The FDA product code for DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST is KTN.

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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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