Cleared Traditional

GOAT LAMBDA-LIGHT CHAIN ANTIHUMAN SERUM (K771239) - FDA 510(k) Clearance

K771239 · G.D. Searle and Co. · Immunology device
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Aug 1977
Decision
22d
Days
-
Risk

K771239 is an FDA 510(k) clearance for the GOAT LAMBDA-LIGHT CHAIN ANTIHUMAN SERUM.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1977 after a review of 22 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 G.D. Searle and Co. devices

Submission Details

510(k) Number K771239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1977
Decision Date August 02, 1977
Days to Decision 22 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 104d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -