Cleared Traditional

STAIN PACK FOR AEROSPRAY SLIDE STAINER

K833260 · Wescor, Inc. · Hematology
Oct 1983
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K833260 is an FDA 510(k) clearance for the STAIN PACK FOR AEROSPRAY SLIDE STAINER, a Wright's Stain (Class I — General Controls, product code IAF), submitted by Wescor, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983, 35 days after receiving the submission on September 23, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K833260 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1983
Decision Date October 28, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code IAF — Wright's Stain
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850

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