Cleared Traditional

K771512 - COUNTER MODEL S PLUS BLOOD CELL COUNTER

K771512 is an FDA 510(k) clearance for COUNTER MODEL S PLUS BLOOD CELL COUNTER, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Chemistry device with product code GKL cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K771512 · Coulter Electronics, Inc. · Chemistry device
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Nov 1977
Decision
93d
Days
Class 2
Risk

K771512 is an FDA 510(k) clearance for the COUNTER MODEL S PLUS BLOOD CELL COUNTER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on November 9, 1977 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.5200 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K771512

510(k) Number K771512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1977
Decision Date November 09, 1977
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 Chemistry devices follow this clearance model.

Regulatory Peers - GKL Counter, Cell, Automated (particle Counter)

All 97
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K771512.
SYSTEM AUTO. BLOOD CELL COUNTER CC-110
K780910 · Toa Medical Electronics USA, Inc. · Jun 1978
SYSMEX PLATELET COUNTER, PL-110
K780911 · Toa Medical Electronics USA, Inc. · Jun 1978
MICROCELL COUNTER MODEL CC-108
K780224 · Toa Medical Electronics USA, Inc. · May 1978
AUTO. LEUCOCYTE DIFFER. ANALYZER D/90
K771728 · Technicon Instruments Corp. · Nov 1977
DETECTOTERGE AZIDE FREE
K771790 · J.T. Baker Chemical Co. · Oct 1977
PLATELET COUNTER & HEMATOCRIT ACCES.
K771353 · Hycel, Inc. · Aug 1977