Cleared Traditional

DIA-H 1/2/3 & DIA-HT 1/2/3 (K840801) - FDA 510(k) Clearance

K840801 · Diatech, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
62d
Days
-
Risk

K840801 is an FDA 510(k) clearance for the DIA-H 1/2/3 & DIA-HT 1/2/3.

Submitted by Diatech, Inc. (Walker, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel. 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 Diatech, Inc. devices

Submission Details

510(k) Number K840801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date April 25, 1984
Days to Decision 62 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 113d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -