Cleared Traditional

WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY

K881512 · Wescor, Inc. · Pathology
Apr 1988
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K881512 is an FDA 510(k) clearance for the WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY, a Stains, Microbiologic (Class I — General Controls, product code JTS), submitted by Wescor, Inc. (Logan, US). The FDA issued a Cleared decision on April 18, 1988, 7 days after receiving the submission on April 11, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K881512 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1988
Decision Date April 18, 1988
Days to Decision 7 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code JTS — Stains, Microbiologic
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850