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FDA 510(k)

VIROGEN RUBELLA MICROTITER TEST

K-Number: K844436 · 1985-05-21

ApplicantArmkel, LLC
Decision Date1985-05-21
Product CodeLQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIROGEN RUBELLA MICROTITER 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 1985-05-21 under 510(k) number K844436. The device is classified under product code LQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIROGEN RUBELLA MICROTITER TEST?

VIROGEN RUBELLA MICROTITER TEST is a medical device that received FDA 510(k) clearance on 1985-05-21. The listed applicant is Armkel, LLC. The 510(k) number is K844436.

When did VIROGEN RUBELLA MICROTITER TEST receive FDA 510(k) clearance?

VIROGEN RUBELLA MICROTITER TEST received FDA 510(k) clearance on 1985-05-21, under 510(k) number K844436.

Who is the listed applicant for VIROGEN RUBELLA MICROTITER 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 VIROGEN RUBELLA MICROTITER TEST?

The FDA product code for VIROGEN RUBELLA MICROTITER TEST is LQN.

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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: LQN)

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.

K031490RUBELLACOLImmunostics Inc.,K970931COPALIS TORC TOTAL ANTIBODY ASSAYSienna Biotech, Inc.K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSSienna Biotech, Inc.K954920MUREX RUB-EXMurex Diagnostics, Inc.K952544COLORSLIDER RUBELLASeradyn, Inc.K912391RUBALEX, MODIFICATIONOrion Corp.

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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