Cleared Traditional

BIO SURE STAIN

K832496 · Helena Laboratories · Chemistry
Sep 1983
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K832496 is an FDA 510(k) clearance for the BIO SURE STAIN, a Alcian Blue (Class I — General Controls, product code IDA), submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 47 days after receiving the submission on July 27, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K832496 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1983
Decision Date September 12, 1983
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code IDA — Alcian Blue
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850