Cleared Traditional

K831653 - LYOPHILIZED MICROORGANISMS
(FDA 510(k) Clearance)

K831653 · Austin Biological Laboratories · Microbiology

Jul 1983

Decision

66d

Days

Class 1

Risk

K831653 is an FDA 510(k) clearance for the LYOPHILIZED MICROORGANISMS, a Kit, Quality Control For Culture Media (Class I — General Controls, product code JTR), submitted by Austin Biological Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983, 66 days after receiving the submission on May 23, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2480.

Submission Details

510(k) Number	K831653 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 1983
Decision Date	July 28, 1983
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—