BACTIGEN S. PNEUMONIAE— 510(k) K831887

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K831887 for BACTIGEN S. PNEUMONIAE, Substantially Equivalent on 1983-09-26. Applicant: Armkel, LLC. Device class: 1.

Clearance details

Applicant: Armkel, LLC
Product code: Code GWC
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1983-06-13
Decision date: 1983-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code GWC

K884965 — BACTIGEN(R) MENINGITIDIS PANEL1989-02-07
K884966 — BACTIGEN(R) S. PNEUMONIAE1989-02-07
K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE1987-03-25
K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-1101986-12-18
K842239 — VENTRESCREEN STREP A TEST1984-07-02

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