Cleared Traditional

K891476 - C. ALBICANS SCREEN
(FDA 510(k) Clearance)

K891476 · Carr-Scarborough Microbiologicals, Inc. · Microbiology

Apr 1989

Decision

27d

Days

Class 1

Risk

K891476 is an FDA 510(k) clearance for the C. ALBICANS SCREEN, a Kit, Screening, Yeast (Class I — General Controls, product code JXC), submitted by Carr-Scarborough Microbiologicals, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on April 12, 1989, 27 days after receiving the submission on March 16, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K891476 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 1989
Decision Date	April 12, 1989
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—