Cleared Traditional

NUTRIENT GELATIN - PRODUCT NUMBER T2860

K880946 · Lakewood Biochemical Co., Inc. · Microbiology
Apr 1988
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K880946 is an FDA 510(k) clearance for the NUTRIENT GELATIN - PRODUCT NUMBER T2860, 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 April 1, 1988, 25 days after receiving the submission on March 7, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K880946 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1988
Decision Date April 01, 1988
Days to Decision 25 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSF — Culture Media, Single Biochemical Test
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2320