Cleared Traditional

K854016 - ASSERACHROM PROTEIN C KIT
(FDA 510(k) Clearance)

K854016 · American Bioproducts Co. · Hematology
Jan 1986
Decision
98d
Days
Class 1
Risk

K854016 is an FDA 510(k) clearance for the ASSERACHROM PROTEIN C KIT. This device is classified as a Conversion To Creatinine, Creatine (Class I — General Controls, product code JLA).

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on January 3, 1986, 98 days after receiving the submission on September 27, 1985.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1210.

Submission Details

510(k) Number K854016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date January 03, 1986
Days to Decision 98 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