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FDA 510(k)

MONO SCREENING TEST

K-Number: K830531 · 1983-03-17

ApplicantTago, Inc.
Decision Date1983-03-17
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MONO SCREENING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Tago, Inc.. It received FDA 510(k) clearance on 1983-03-17 under 510(k) number K830531. 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 MONO SCREENING TEST?

MONO SCREENING TEST is a medical device that received FDA 510(k) clearance on 1983-03-17. The listed applicant is Tago, Inc.. The 510(k) number is K830531.

When did MONO SCREENING TEST receive FDA 510(k) clearance?

MONO SCREENING TEST received FDA 510(k) clearance on 1983-03-17, under 510(k) number K830531.

Who is the listed applicant for MONO SCREENING TEST?

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

What is the FDA product code for MONO SCREENING TEST?

The FDA product code for MONO SCREENING TEST is KTN.

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Other records listing Tago, 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.

K841734TAGO FIFFU-GEN, OROSOMUCOIDK841265TAGO DIFFU-GEN C-REACTIVE PROTEINK834218DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -K840404DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNOK833129TAGO DIFFU-GEN-APOLIPOPROTEIN B-100K830611RA SCREENING TEST

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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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