Cleared Traditional

K760484 - STAIN SET, HISTOCHEMICAL AFB (FDA 510(k) Clearance)

K760484 · Harleco · Hematology device
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Sep 1976
Decision
14d
Days
-
Risk

K760484 is an FDA 510(k) clearance for the STAIN SET, HISTOCHEMICAL AFB.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 3, 1976 after a review of 14 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 Harleco devices

Submission Details

510(k) Number K760484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1976
Decision Date September 03, 1976
Days to Decision 14 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 113d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -