Cleared Traditional

K930913 - COULTER MH015 (DIFFERENTIAL CELL COUNTER)

K930913 is the FDA 510(k) clearance for COULTER MH015 (DIFFERENTIAL CELL COUNTER) by Coulter Corp.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K930913 · Coulter Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
182d
Days
Class 2
Risk

K930913 is an FDA 510(k) clearance for the COULTER MH015 (DIFFERENTIAL CELL COUNTER). Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 182 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Corp. devices

Submission Details

510(k) Number K930913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1993
Decision Date August 23, 1993
Days to Decision 182 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
69d slower than avg
Panel avg: 113d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 193
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K930913.
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K943284 · Dako Corp. · Nov 1994
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K944253 · Dako Corp. · Nov 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL
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K932030 · Coulter Corp. · Aug 1993
ABBOTT ENCOUNTER(TM)Q
K930309 · Abbott Laboratories · Jul 1993
CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
K926124 · Coulter Corp. · Jul 1993