Cleared Traditional

WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S

K852138 · Canyon Diagnostics, Inc. · Pathology
Jun 1985
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K852138 is an FDA 510(k) clearance for the WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S, a Wright's Stain (Class I — General Controls, product code IAF), submitted by Canyon Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 13, 1985, 28 days after receiving the submission on May 16, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K852138 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1985
Decision Date June 13, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
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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