Cleared Traditional

GENERAL DIAGNOSTICS COAG-A-MATE XC

K852843 · Warner-Lambert Co. · Hematology
Aug 1985
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K852843 is an FDA 510(k) clearance for the GENERAL DIAGNOSTICS COAG-A-MATE XC, a Stains, Hematology (Class I — General Controls, product code KQC), submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on August 13, 1985, 39 days after receiving the submission on July 5, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K852843 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 1985
Decision Date August 13, 1985
Days to Decision 39 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KQC — Stains, Hematology
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850