Cleared Traditional

HA ANTIGEN (K760606) - FDA 510(k) Clearance

K760606 · Flow Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1976
Decision
29d
Days
-
Risk

K760606 is an FDA 510(k) clearance for the HA ANTIGEN.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 8, 1976 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology 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 Flow Laboratories, Inc. devices

Submission Details

510(k) Number K760606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1976
Decision Date October 08, 1976
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -