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FDA 510(k)

BACTIGEN-N. MENINGITIDIS

K-Number: K823880 · 1983-03-09

ApplicantArmkel, LLC
Decision Date1983-03-09
Product CodeGTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTIGEN-N. MENINGITIDIS is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1983-03-09 under 510(k) number K823880. 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. MENINGITIDIS?

BACTIGEN-N. MENINGITIDIS is a medical device that received FDA 510(k) clearance on 1983-03-09. The listed applicant is Armkel, LLC. The 510(k) number is K823880.

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

BACTIGEN-N. MENINGITIDIS received FDA 510(k) clearance on 1983-03-09, under 510(k) number K823880.

Who is the listed applicant for BACTIGEN-N. MENINGITIDIS?

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. MENINGITIDIS?

The FDA product code for BACTIGEN-N. MENINGITIDIS is GTJ.

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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: GTJ)

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.

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.K854852WELLCOGEN BACTERIAL ANTIGEN KITWellcome 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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