Cleared Traditional

WESCOR MODEL 7300 AEROSPRAY GRAM STAINER

K881592 · Wescor, Inc. · Pathology
May 1988
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K881592 is an FDA 510(k) clearance for the WESCOR MODEL 7300 AEROSPRAY GRAM STAINER, a Slide Stainer, Automated (Class I — General Controls, product code KPA), submitted by Wescor, Inc. (Logan, US). The FDA issued a Cleared decision on May 13, 1988, 31 days after receiving the submission on April 12, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3800.

Submission Details

510(k) Number K881592 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1988
Decision Date May 13, 1988
Days to Decision 31 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

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