Cleared Traditional

LYSING AGENT AF

K761183 · Central Labs. Assoc. MD Pathologists · Pathology
Jan 1977
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K761183 is an FDA 510(k) clearance for the LYSING AGENT AF, a Solution, Isotonic (Class I — General Controls, product code JCE), submitted by Central Labs. Assoc. MD Pathologists (Mchenry, US). The FDA issued a Cleared decision on January 17, 1977, 46 days after receiving the submission on December 2, 1976. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K761183 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1976
Decision Date January 17, 1977
Days to Decision 46 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code JCE — Solution, Isotonic
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010