Cleared Traditional

K971636 - RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
(FDA 510(k) Clearance)

K971636 · Oxoid , Ltd. · Microbiology

Jan 1998

Decision

271d

Days

Class 2

Risk

K971636 is an FDA 510(k) clearance for the RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on January 28, 1998, 271 days after receiving the submission on May 2, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number	K971636 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 1997
Decision Date	January 28, 1998
Days to Decision	271 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement