Cleared Traditional

K833295 - WESCOR 7100 AEROSPRAY SLIDE STAINER
(FDA 510(k) Clearance)

K833295 · Wescor, Inc. · Hematology
Oct 1983
Decision
38d
Days
Class 1
Risk

K833295 is an FDA 510(k) clearance for the WESCOR 7100 AEROSPRAY SLIDE STAINER, a Slide Stainer, Automated (Class I — General Controls, product code KPA), submitted by Wescor, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983, 38 days after receiving the submission on September 23, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 864.3800.

Submission Details

510(k) Number K833295 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1983
Decision Date October 31, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KPA — Slide Stainer, Automated
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3800