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FDA 510(k)

INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST

K-Number: K880148 · 1988-02-10

ApplicantAmpcor, Inc.
Decision Date1988-02-10
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Ampcor, Inc.. It received FDA 510(k) clearance on 1988-02-10 under 510(k) number K880148. 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 INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST?

INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST is a medical device that received FDA 510(k) clearance on 1988-02-10. The listed applicant is Ampcor, Inc.. The 510(k) number is K880148.

When did INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST receive FDA 510(k) clearance?

INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST received FDA 510(k) clearance on 1988-02-10, under 510(k) number K880148.

Who is the listed applicant for INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST?

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

What is the FDA product code for INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST?

The FDA product code for INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST is KTN.

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Other records listing Ampcor, 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.

K922296IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TESTK922297INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TESTK910438DIPSTICK SALMONELLAK893873SINGLE AND DUAL BAND DIPSTICK HCG TESTK890048QUIK-DOT TOXOPLASMOSISK892146C REACTIVE PROTEIN LIQUID

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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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