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FDA 510(k)

BACTIGEN(R) N. MENINGITIDIS

K-Number: K885004 · 1989-02-07

ApplicantArmkel, LLC
Decision Date1989-02-07
Product CodeGTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTIGEN(R) 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 1989-02-07 under 510(k) number K885004. 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(R) N. MENINGITIDIS?

BACTIGEN(R) N. MENINGITIDIS is a medical device that received FDA 510(k) clearance on 1989-02-07. The listed applicant is Armkel, LLC. The 510(k) number is K885004.

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

BACTIGEN(R) N. MENINGITIDIS received FDA 510(k) clearance on 1989-02-07, under 510(k) number K885004.

Who is the listed applicant for BACTIGEN(R) 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(R) N. MENINGITIDIS?

The FDA product code for BACTIGEN(R) N. MENINGITIDIS is GTJ.

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Other records listing Armkel, LLC as applicant

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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.K870089IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KITMicroscan Div. Baxter Healthcare Corp.K854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24Wellcome DiagnosticsK854852WELLCOGEN 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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