Cleared Traditional

TECHNICON H*1 SYSTEM (K852787) - FDA 510(k) Clearance

K852787 · Technicon Instruments Corp. · Hematology device
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Jul 1985
Decision
22d
Days
-
Risk

K852787 is an FDA 510(k) clearance for the TECHNICON H*1 SYSTEM.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 23, 1985 after a review of 22 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K852787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date July 23, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 113d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -