Cleared Traditional

MULTI-GRAM DEVELOPING TANK R-12 & R-3

K812919 · Marion Laboratories, Inc. · Toxicology

Nov 1981

Decision

14d

Days

Class 1

Risk

About This 510(k) Submission

K812919 is an FDA 510(k) clearance for the MULTI-GRAM DEVELOPING TANK R-12 & R-3, a Tanks, Developing, Tlc (Class I — General Controls, product code DKK), submitted by Marion Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1981, 14 days after receiving the submission on October 19, 1981. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2270.

Submission Details

510(k) Number	K812919 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 1981
Decision Date	November 02, 1981
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—