Cleared Traditional

K790025 - COUNTER CHECK, H001, H002, H003 (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K790025 · Diagnostic Technology, Inc. · Hematology device
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Jan 1979
Decision
14d
Days
Class 2
Risk

K790025 is an FDA 510(k) clearance for the COUNTER CHECK, H001, H002, H003. Classified as Kit, Quality Control For Blood Banking Reagents (product code KSF), Class II - Special Controls.

Submitted by Diagnostic Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9650 - 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 Diagnostic Technology, Inc. devices

Submission Details

510(k) Number K790025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1979
Decision Date January 17, 1979
Days to Decision 14 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 113d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSF Kit, Quality Control For Blood Banking Reagents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9650
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.