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FDA 510(k)

DRYSPOT INFECTIOUS MONONUCLEOSIS KIT

K-Number: K982634 · 1999-01-28

ApplicantOxoid , Ltd.
Decision Date1999-01-28
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DRYSPOT INFECTIOUS MONONUCLEOSIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid , Ltd.. It received FDA 510(k) clearance on 1999-01-28 under 510(k) number K982634. 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 DRYSPOT INFECTIOUS MONONUCLEOSIS KIT?

DRYSPOT INFECTIOUS MONONUCLEOSIS KIT is a medical device that received FDA 510(k) clearance on 1999-01-28. The listed applicant is Oxoid , Ltd.. The 510(k) number is K982634.

When did DRYSPOT INFECTIOUS MONONUCLEOSIS KIT receive FDA 510(k) clearance?

DRYSPOT INFECTIOUS MONONUCLEOSIS KIT received FDA 510(k) clearance on 1999-01-28, under 510(k) number K982634.

Who is the listed applicant for DRYSPOT INFECTIOUS MONONUCLEOSIS KIT?

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

What is the FDA product code for DRYSPOT INFECTIOUS MONONUCLEOSIS KIT?

The FDA product code for DRYSPOT INFECTIOUS MONONUCLEOSIS KIT is KTN.

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Other records listing Oxoid , Ltd. 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.

K070262ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISCK060286TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISCK042157DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCK011710OXOID PBP2 1 LATEX AGGLUTINATION TESTK012588OXOID PYLORI TEST KIT, MODEL DR0130MK010537LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

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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 COK981946CLEARVIEW IMUnipath , Ltd.K972457MONOCOL/LEX-IM TESTImmunostics Inc.,

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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