Cleared Traditional

RETICULOCYTE STAIN

K875310 · Sigma Diagnostics, Inc. · Pathology
Feb 1988
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K875310 is an FDA 510(k) clearance for the RETICULOCYTE STAIN, a Methylene Blue, Tissue Stain (Class I — General Controls, product code KFC), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 9, 1988, 42 days after receiving the submission on December 29, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K875310 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1987
Decision Date February 09, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KFC — Methylene Blue, Tissue Stain
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850

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