Cleared Traditional

K842853 - LYSINE IRON AGAR (FDA 510(k) Clearance)

K842853 · Anarobe Systems · Microbiology device

Aug 1984

Decision

14d

Days

Class 1

Risk

K842853 is an FDA 510(k) clearance for the LYSINE IRON AGAR. This device is classified as a Culture Media, Single Biochemical Test (Class I - General Controls, product code JSF).

Submitted by Anarobe Systems (Walker, US). The FDA issued a Cleared decision on August 3, 1984, 14 days after receiving the submission on July 20, 1984.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number	K842853 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 20, 1984
Decision Date	August 03, 1984
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—