Cleared Traditional

T3 UPTAKE DIAG. KIT (K771585) - FDA 510(k) Clearance

K771585 · Antibodies, Inc. · Chemistry device
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Sep 1977
Decision
26d
Days
-
Risk

K771585 is an FDA 510(k) clearance for the T3 UPTAKE DIAG. KIT.

Submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1977 after a review of 26 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 Antibodies, Inc. devices

Submission Details

510(k) Number K771585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1977
Decision Date September 13, 1977
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -