Cleared Traditional

K832763 - TOBRAMYCIN REAGENT

K832763 is an FDA 510(k) clearance for TOBRAMYCIN REAGENT, manufactured by Biosan Laboratories, Inc.. The device is a Class 2 Chemistry device with product code KLB cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K832763 · Biosan Laboratories, Inc. · Chemistry device
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Mar 1984
Decision
220d
Days
Class 2
Risk

K832763 is an FDA 510(k) clearance for the TOBRAMYCIN REAGENT. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by Biosan Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 220 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3900 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosan Laboratories, Inc. devices

FDA 510(k) Submission Details - K832763

510(k) Number K832763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1983
Decision Date March 23, 1984
Days to Decision 220 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 88d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLB Device Classification - Class 2, Special Controls

Product Code KLB Radioimmunoassay, Tobramycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3900
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 Chemistry devices follow this clearance model.

Regulatory Peers - KLB Radioimmunoassay, Tobramycin

All 19
Devices cleared under the same product code (KLB) and FDA review panel - the closest regulatory comparables to K832763.
EMIT TOBRAMYCIN ASSAY
K874223 · Syva Co. · Nov 1987
IN-VITRO TEST DETERMINATION OF TOBRAMYCIN
K854184 · Clinical Data, Inc. · Dec 1985
ACA TOBRAMY-CIN ANALYTICAL TEST PACK
K852671 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1985
TOBRAMYCIN ANALYTICAL TEST PACK-ACA
K832985 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1983
COAT-A-COUNT TOBRAMYCIN RIA KIT
K822858 · Diagnostic Products Corp. · Oct 1982
KALLESTAD ANTISERA TO TOBRAMYCIN
K812415 · Kallestad Laboratories, Inc. · Sep 1981