Cleared Traditional

AUSTIN NONFERMENTER KIT

K870769 · Austin Biological Laboratories · Microbiology

Apr 1987

Decision

36d

Days

Class 1

Risk

About This 510(k) Submission

K870769 is an FDA 510(k) clearance for the AUSTIN NONFERMENTER KIT, a Kit, Identification, Glucose Nonfermenter (Class I — General Controls, product code JSW), submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on April 3, 1987, 36 days after receiving the submission on February 26, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K870769 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 1987
Decision Date	April 03, 1987
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—