Cleared Traditional

K770815 - ULTRAZYME PLUS GT (FDA 510(k) Clearance)

K770815 · Harleco · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1977
Decision
68d
Days
-
Risk

K770815 is an FDA 510(k) clearance for the ULTRAZYME PLUS GT.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on July 11, 1977 after a review of 68 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 K770815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1977
Decision Date July 11, 1977
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -