Cleared Traditional

K873828 - CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990
(FDA 510(k) Clearance)

K873828 · Lakewood Biochemical Co., Inc. · Microbiology device

Oct 1987

Decision

15d

Days

Class 1

Risk

K873828 is an FDA 510(k) clearance for the CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990. This device is classified as a Culture Media, Single Biochemical Test (Class I - General Controls, product code JSF).

Submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on October 6, 1987, 15 days after receiving the submission on September 21, 1987.

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

Submission Details

510(k) Number	K873828 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 21, 1987
Decision Date	October 06, 1987
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—