Cleared Traditional

K874188 - COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA

K874188 is an FDA 510(k) clearance for COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMM..., manufactured by Coulter Electronics, Inc.. The device is a Class 1 Hematology device with product code GKM cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K874188 · Coulter Electronics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1988
Decision
97d
Days
Class 1
Risk

K874188 is an FDA 510(k) clearance for the COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA. Classified as Hand-tally, Differential (product code GKM), Class I - General Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6160 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K874188

510(k) Number K874188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1987
Decision Date January 19, 1988
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 113d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

GKM Device Classification - Class 1, General Controls

Product Code GKM Hand-tally, Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6160
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.