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FDA 510(k)

BACTIGEN - N.MENNINIGITIDIS TEST

K-Number: K841907 · 1984-07-06

ApplicantArmkel, LLC
Decision Date1984-07-06
Product CodeGTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTIGEN - N.MENNINIGITIDIS 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 1984-07-06 under 510(k) number K841907. The device is classified under product code GTJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTIGEN - N.MENNINIGITIDIS TEST?

BACTIGEN - N.MENNINIGITIDIS TEST is a medical device that received FDA 510(k) clearance on 1984-07-06. The listed applicant is Armkel, LLC. The 510(k) number is K841907.

When did BACTIGEN - N.MENNINIGITIDIS TEST receive FDA 510(k) clearance?

BACTIGEN - N.MENNINIGITIDIS TEST received FDA 510(k) clearance on 1984-07-06, under 510(k) number K841907.

Who is the listed applicant for BACTIGEN - N.MENNINIGITIDIS 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 BACTIGEN - N.MENNINIGITIDIS TEST?

The FDA product code for BACTIGEN - N.MENNINIGITIDIS TEST is GTJ.

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Other records listing Armkel, LLC as applicant

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Related Devices (Code: GTJ)

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K952791DIRECTIGEN MENINGITIS COMBO TESTBd Becton Dickinson Vacutainer Systems PreanalyticK915330DIRECTIGEN MENINGITIS COMBO TEST KITBd Becton Dickinson Vacutainer Systems PreanalyticK910210SLIDEX MENINGITE-KIT 5Vitek Systems, Inc.K885004BACTIGEN(R) N. MENINGITIDISArmkel, LLCK870089IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KITMicroscan Div. Baxter Healthcare Corp.K854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24Wellcome Diagnostics

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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