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FDA 510(k)

SERO/TEX MONO TEST

K-Number: K821386 · 1982-07-02

ApplicantTexas Immunology, Inc.
Decision Date1982-07-02
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SERO/TEX MONO TEST is the device name listed in this FDA 510(k) record. The listed applicant is Texas Immunology, Inc.. It received FDA 510(k) clearance on 1982-07-02 under 510(k) number K821386. 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 SERO/TEX MONO TEST?

SERO/TEX MONO TEST is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Texas Immunology, Inc.. The 510(k) number is K821386.

When did SERO/TEX MONO TEST receive FDA 510(k) clearance?

SERO/TEX MONO TEST received FDA 510(k) clearance on 1982-07-02, under 510(k) number K821386.

Who is the listed applicant for SERO/TEX MONO TEST?

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

What is the FDA product code for SERO/TEX MONO TEST?

The FDA product code for SERO/TEX MONO TEST is KTN.

Other records listing Texas Immunology, 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.

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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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