Cleared Traditional

K852843 - GENERAL DIAGNOSTICS COAG-A-MATE XC (FDA 510(k) Clearance)

Class I Hematology device.

K852843 · Warner-Lambert Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
39d
Days
Class 1
Risk

K852843 is an FDA 510(k) clearance for the GENERAL DIAGNOSTICS COAG-A-MATE XC. Classified as Stains, Hematology (product code KQC), Class I - General Controls.

Submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on August 13, 1985 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.1850 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Warner-Lambert Co. devices

Submission Details

510(k) Number K852843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1985
Decision Date August 13, 1985
Days to Decision 39 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 113d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQC Stains, Hematology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.