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FDA 510(k)

MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET

K-Number: K900625 · 1990-02-26

ApplicantArmkel, LLC
Decision Date1990-02-26
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1990-02-26 under 510(k) number K900625. 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-PLUS POSITIVE AND NEGATIVE CONTROL SET?

MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET is a medical device that received FDA 510(k) clearance on 1990-02-26. The listed applicant is Armkel, LLC. The 510(k) number is K900625.

When did MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET receive FDA 510(k) clearance?

MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET received FDA 510(k) clearance on 1990-02-26, under 510(k) number K900625.

Who is the listed applicant for MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET?

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

What is the FDA product code for MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET?

The FDA product code for MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET is KTN.

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Other records listing Armkel, LLC as applicant

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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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