Cleared Traditional

HEMO-SOL

K874461 · Chem Pharm, Inc. · Pathology
Dec 1987
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K874461 is an FDA 510(k) clearance for the HEMO-SOL, a Agent, Clearing (Class I — General Controls, product code KEM), submitted by Chem Pharm, Inc. (Dallas, US). The FDA issued a Cleared decision on December 4, 1987, 36 days after receiving the submission on October 29, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K874461 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1987
Decision Date December 04, 1987
Days to Decision 36 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KEM — Agent, Clearing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010