Cleared Traditional

RADIOASSAY, CONCEPT 4 (K760006) - FDA 510(k) Clearance

K760006 · Micromedic Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1976
Decision
43d
Days
-
Risk

K760006 is an FDA 510(k) clearance for the RADIOASSAY, CONCEPT 4.

Submitted by Micromedic Systems (Walker, US). The FDA issued a Cleared decision on July 20, 1976 after a review of 43 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 Micromedic Systems devices

Submission Details

510(k) Number K760006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1976
Decision Date July 20, 1976
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -