BACTIGEN - N.MENNINIGITIDIS TEST— 510(k) K841907

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K841907 for BACTIGEN - N.MENNINIGITIDIS TEST, Substantially Equivalent on 1984-07-06. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code GTJ
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1984-05-08
Decision date: 1984-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GTJ

K952791 — DIRECTIGEN MENINGITIS COMBO TEST1996-05-30
K915330 — DIRECTIGEN MENINGITIS COMBO TEST KIT1992-03-23
K910210 — SLIDEX MENINGITE-KIT 51991-08-12
K885004 — BACTIGEN(R) N. MENINGITIDIS1989-02-07
K870089 — IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT1987-03-17

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Data sourced from openFDA. This site is unofficial and independent of the FDA.