Cleared Traditional

K840794 - S-CAL HEMATOLOGY CALIBRATOR

K840794 is the FDA 510(k) clearance for S-CAL HEMATOLOGY CALIBRATOR by Coulter Electronics, Inc.. It is a Class 2 Hematology device (product code KRY) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K840794 · Coulter Electronics, Inc. · Hematology device
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Apr 1984
Decision
41d
Days
Class 2
Risk

K840794 is an FDA 510(k) clearance for the S-CAL HEMATOLOGY CALIBRATOR. Classified as Calibrator For Platelet Counting (product code KRY), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8175 - 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 K840794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date April 04, 1984
Days to Decision 41 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
72d faster than avg
Panel avg: 113d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRY Calibrator For Platelet Counting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8175
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 - KRY Calibrator For Platelet Counting

Devices cleared under the same product code (KRY) and FDA review panel - the closest regulatory comparables to K840794.
S-CAL HEMATOLOGY CALIBRATOR
K862122 · Coulter Electronics, Inc. · May 1987
LASER PLATELETCAL/MULTIPLE
K852016 · R&D Systems, Inc. · Jul 1985
COULTER MEAN PLATELET VOLUME CALIBRATOR
K843910 · Coulter Electronics, Inc. · Jan 1985
TEKNI-CAL
K781601 · Streck Laboratories, Inc. · Oct 1978
PC-CALIBRATOR
K781133 · Streck Laboratories, Inc. · Aug 1978
TQC CALIBRATION REFERENCE FOR PLATELETS
K770143 · Technicon Instruments Corp. · Jan 1978