Cleared Traditional

FIELDTEX HEMATOXYLIN

K882873 · Anatech, Ltd. · Pathology
Jul 1988
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K882873 is an FDA 510(k) clearance for the FIELDTEX HEMATOXYLIN, a Stains, Hematology (Class I — General Controls, product code KQC), submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on July 28, 1988, 17 days after receiving the submission on July 11, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K882873 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1988
Decision Date July 28, 1988
Days to Decision 17 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KQC — Stains, Hematology
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850