Cleared Traditional

K834021 - SYSMEX CC-780 EIGHT PARAMETER AUT0

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

FDA 510(k) Submission Details - K834021

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 113d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -