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FDA 510(k)

MONO-LATEX (TM) SLIDE TEST

K-Number: K862008 · 1986-07-03

ApplicantArmkel, LLC
Decision Date1986-07-03
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MONO-LATEX (TM) SLIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1986-07-03 under 510(k) number K862008. 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-LATEX (TM) SLIDE TEST?

MONO-LATEX (TM) SLIDE TEST is a medical device that received FDA 510(k) clearance on 1986-07-03. The listed applicant is Armkel, LLC. The 510(k) number is K862008.

When did MONO-LATEX (TM) SLIDE TEST receive FDA 510(k) clearance?

MONO-LATEX (TM) SLIDE TEST received FDA 510(k) clearance on 1986-07-03, under 510(k) number K862008.

Who is the listed applicant for MONO-LATEX (TM) SLIDE TEST?

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-LATEX (TM) SLIDE TEST?

The FDA product code for MONO-LATEX (TM) SLIDE TEST is KTN.

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Other records listing Armkel, LLC 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.

K040866FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTK030258FIRST RESPONSE PREGNANCY TESTK023405TROJAN MINT TINGLE BRAND LATEX CONDOMSK013433TROJAN PASSION BERRY GELK013614TROJAN CRYSTAL CLEAR LIQUIDK001212TROJAN EXTRA LARGE LATEX CONDOM

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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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