Cleared Traditional

SYSMEX CC-780 EIGHT PARAMETER AUT0 (K834021) - FDA 510(k) Clearance

K834021 · Toa Medical Electronics USA, Inc. · Hematology device
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Mar 1984
Decision
101d
Days
-
Risk

K834021 is an FDA 510(k) clearance for the SYSMEX CC-780 EIGHT PARAMETER AUT0.

Submitted by Toa Medical Electronics USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1984 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toa Medical Electronics USA, Inc. devices

Submission Details

510(k) Number K834021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1983
Decision Date March 02, 1984
Days to Decision 101 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 113d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -