Cleared Traditional

K792261 - GENTAMICIN CONTROL SERUM

K792261 is an FDA 510(k) clearance for GENTAMICIN CONTROL SERUM, manufactured by Hemometrix. The device is a Class 1 Toxicology device with product code LAS cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K792261 · Hemometrix · Toxicology device
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Dec 1979
Decision
39d
Days
Class 1
Risk

K792261 is an FDA 510(k) clearance for the GENTAMICIN CONTROL SERUM. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Hemometrix (Mchenry, US). The FDA issued a Cleared decision on December 18, 1979 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology 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.

FDA 510(k) Submission Details - K792261

510(k) Number K792261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1979
Decision Date December 18, 1979
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 87d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

LAS Device Classification - Class 1, General Controls

Product Code LAS Drug Specific 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 - LAS Drug Specific Control Materials

All 82
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K792261.
BI-LEVEL ASSAYED CARD. DRUG CONT., I,II
K800357 · Ortho Diagnostics, Inc. · Apr 1980
AMIKACIN CONTROL SERUM
K792259 · Hemometrix · Dec 1979
AMIKACIN LIQUID CONTROL SERUM
K792260 · Hemometrix · Dec 1979
GENTAMICIN LIQUID CONTROL SERUM
K792262 · Hemometrix · Dec 1979
TOBRAMYCIN CONTROL SERUM
K792263 · Hemometrix · Dec 1979
TOBRAMYCIN LIQUID CONTROL SERUM
K792264 · Hemometrix · Dec 1979
K792261 · GENTAMICIN CONTROL SERUM
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