Cleared Traditional

K772031 - GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT (FDA 510(k) Clearance)

K772031 · Harleco · Chemistry device
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Nov 1977
Decision
18d
Days
-
Risk

K772031 is an FDA 510(k) clearance for the GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on November 14, 1977 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry 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 K772031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1977
Decision Date November 14, 1977
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -