Cleared Traditional

K813349 - BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL

K813349 is the FDA 510(k) clearance for BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL by Stanbio Laboratory. It is a Class 1 Microbiology device (product code DIF) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K813349 · Stanbio Laboratory · Microbiology device
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Dec 1981
Decision
25d
Days
Class 1
Risk

K813349 is an FDA 510(k) clearance for the BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Stanbio Laboratory (Mchenry, US). The FDA issued a Cleared decision on December 22, 1981 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.3280 - the FDA microbiology device framework. 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 Stanbio Laboratory devices

Submission Details

510(k) Number K813349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1981
Decision Date December 22, 1981
Days to Decision 25 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIF Drug Mixture Control Materials

All 131
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K810504 · Fisher Scientific Co., LLC · Mar 1981