Cleared Traditional

K813391 - TOBRAMYCIN REAGENT TEST KIT (FDA 510(k) Clearance)

K813391 · Beckman Instruments, Inc. · Toxicology device
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Dec 1981
Decision
15d
Days
-
Risk

K813391 is an FDA 510(k) clearance for the TOBRAMYCIN REAGENT TEST KIT. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Beckman Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on December 18, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Toxicology 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K813391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1981
Decision Date December 18, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 87d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKB Pad, Alcohol, Device Disinfectant
Device Class -