BACTIGEN(R) S. PNEUMONIAE— 510(k) K884966

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K884966 for BACTIGEN(R) S. PNEUMONIAE, Substantially Equivalent on 1989-02-07. 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: 1988-11-30
Decision date: 1989-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, US

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Recent devices under product code GWC

K884965 — BACTIGEN(R) MENINGITIDIS PANEL1989-02-07
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
K841376 — WELLCOGEN S. PNEUMONIAE1984-05-02

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K013433 — TROJAN PASSION BERRY GEL2002-03-05
K013614 — TROJAN CRYSTAL CLEAR LIQUID2002-02-01

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