Cleared Traditional

K832953 - MUCICARMINE STAIN, #HT30
(FDA 510(k) Clearance)

K832953 · Sigma Chemical Co. · Chemistry
Sep 1983
Decision
29d
Days
Class 1
Risk

K832953 is an FDA 510(k) clearance for the MUCICARMINE STAIN, #HT30, a Mucicarmine (Class I — General Controls, product code HZC), submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983, 29 days after receiving the submission on August 31, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K832953 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1983
Decision Date September 29, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code HZC — Mucicarmine
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850