ERYTHOCYTE CREATINE— 510(k) K852767

Substantially Equivalent

Panmed, Inc.

FDA 510(k) clearance K852767 for ERYTHOCYTE CREATINE, Substantially Equivalent on 1986-11-13. Applicant: Panmed, Inc.. Device class: 1.

Clearance details

Applicant: Panmed, Inc.
Product code: Code JLA
Device class: Class 1
Regulation: 21 CFR 862.1210
Advisory panel: Clinical Chemistry
Date received: 1985-06-28
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Three Oaks, MI, US

Download summary PDF View on FDA.gov ↗

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K802156 — REAGENTS SERUM CREATINE USING TECHICON1980-10-10
K802157 — BCG REAGENT SERUM ALBUMIN W/TECHNICON1980-10-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.