Cleared Traditional

K884966 - BACTIGEN(R) S. PNEUMONIAE
(FDA 510(k) Clearance)

K884966 · Armkel, LLC · Microbiology

Feb 1989

Decision

69d

Days

Class 1

Risk

K884966 is an FDA 510(k) clearance for the BACTIGEN(R) S. PNEUMONIAE. This device is classified as a Antisera, All Types, Streptococcus Pneumoniae (Class I — General Controls, product code GWC).

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 7, 1989, 69 days after receiving the submission on November 30, 1988.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K884966 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 1988
Decision Date	February 07, 1989
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—