Cleared Traditional

TEST, MACROGLOBULIN KIT (ALPHA2) (K760396) - FDA 510(k) Clearance

K760396 · Kallestad Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1976
Decision
20d
Days
-
Risk

K760396 is an FDA 510(k) clearance for the TEST, MACROGLOBULIN KIT (ALPHA2).

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 26, 1976 after a review of 20 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K760396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1976
Decision Date August 26, 1976
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -