Cleared Traditional

TEKTALLY II (K771580) - FDA 510(k) Clearance

Class I Hematology device.

K771580 · Scientific Products · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1977
Decision
15d
Days
Class 1
Risk

K771580 is an FDA 510(k) clearance for the TEKTALLY II. Classified as Hand-tally, Differential (product code GKM), Class I - General Controls.

Submitted by Scientific Products (Mchenry, US). The FDA issued a Cleared decision on September 2, 1977 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6160 - 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 Scientific Products devices

Submission Details

510(k) Number K771580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1977
Decision Date September 02, 1977
Days to Decision 15 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 113d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GKM Hand-tally, Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.