Cleared Traditional

TUBES, HYDROLYSIS, CALIBRATED (K770605) - FDA 510(k) Clearance

K770605 · Organon, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1977
Decision
76d
Days
-
Risk

K770605 is an FDA 510(k) clearance for the TUBES, HYDROLYSIS, CALIBRATED.

Submitted by Organon, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1977 after a review of 76 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 Organon, Inc. devices

Submission Details

510(k) Number K770605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1977
Decision Date June 15, 1977
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -