Cleared Traditional

K930119 - COULTER RETIC-C CELL CONTROL

K930119 is the FDA 510(k) clearance for COULTER RETIC-C CELL CONTROL by Coulter Electronics, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K930119 · Coulter Electronics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
83d
Days
Class 2
Risk

K930119 is an FDA 510(k) clearance for the COULTER RETIC-C CELL CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on April 5, 1993 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Coulter Electronics, Inc. devices

Submission Details

510(k) Number K930119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1993
Decision Date April 05, 1993
Days to Decision 83 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 113d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JPK Mixture, Hematology Quality Control

All 133
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K930119.
CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE
K940089 · R&D Systems, Inc. · Mar 1994
SE-CHECK
K940181 · Streck Laboratories, Inc. · Mar 1994
CHECKPOINT
K931947 · Medical Specialties, Inc. · Jun 1993
QC-CHEX
K923971 · Streck Laboratories, Inc. · Nov 1992
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE
K913879 · R&D Systems, Inc. · Nov 1991
PX COULTER(R) CELL CONTROL
K912133 · Coulter Electronics, Inc. · Jul 1991