Cleared Traditional

GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR

K873413 · Lakewood Biochemical Co., Inc. · Pathology
Oct 1987
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K873413 is an FDA 510(k) clearance for the GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on October 6, 1987, 43 days after receiving the submission on August 24, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K873413 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1987
Decision Date October 06, 1987
Days to Decision 43 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code JTS — Stains, Microbiologic
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850