Cleared Traditional

K832982 - ACA TOBRAMYCIN CALIBRATOR

K832982 is the FDA 510(k) clearance for ACA TOBRAMYCIN CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K832982 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Oct 1983
Decision
55d
Days
Class 2
Risk

K832982 is an FDA 510(k) clearance for the ACA TOBRAMYCIN CALIBRATOR. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1983 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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.

View all E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K832982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1983
Decision Date October 27, 1983
Days to Decision 55 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
32d faster than avg
Panel avg: 87d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 93
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K832982.
LIDOAINE CALIBRATOR
K833380 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
VALPROIC ACID CALIBRATOR
K833382 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
PROCAINAMIDE CALIBRATOR
K833383 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
THEOPHYLLINE ACA CALIBRATOR
K831933 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1983
EMIT SERUM TRICYCLIC ANTIDEPRESS CALIBRA
K831980 · Syva Co. · Jul 1983
GENTAMICIN CALIBRATOR -ACA
K831209 · E.I. Dupont DE Nemours & Co., Inc. · May 1983