Cleared Traditional

ERYTHOCYTE CREATINE

K852767 · Panmed, Inc. · Hematology
Nov 1986
Decision
503d
Days
Class 1
Risk

About This 510(k) Submission

K852767 is an FDA 510(k) clearance for the ERYTHOCYTE CREATINE, a Conversion To Creatinine, Creatine (Class I — General Controls, product code JLA), submitted by Panmed, Inc. (Three Oaks, US). The FDA issued a Cleared decision on November 13, 1986, 503 days after receiving the submission on June 28, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1210.

Submission Details

510(k) Number K852767 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1985
Decision Date November 13, 1986
Days to Decision 503 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JLA — Conversion To Creatinine, Creatine
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1210