Cleared Traditional

K800743 - TOBRAMYCIN RIA KIT

K800743 is the FDA 510(k) clearance for TOBRAMYCIN RIA KIT by Antibodies, Inc.. It is a Class 2 Toxicology device (product code KLB) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K800743 · Antibodies, Inc. · Toxicology device

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Apr 1980

Decision

13d

Days

Class 2

Risk

K800743 is an FDA 510(k) clearance for the TOBRAMYCIN RIA KIT. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3900 - 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 Antibodies, Inc. devices

Submission Details

510(k) Number	K800743 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 03, 1980
Decision Date	April 16, 1980
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

74d faster than avg

Panel avg: 87d · This submission: 13d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 Toxicology devices follow this clearance model.

Regulatory Peers - KLB Radioimmunoassay, Tobramycin

All 17

Devices cleared under the same product code (KLB) and FDA review panel - the closest regulatory comparables to K800743.

COAT-A-COUNT TOBRAMYCIN RIA KIT

K822858 · Diagnostic Products Corp. · Oct 1982

KALLESTAD ANTISERA TO TOBRAMYCIN

K812415 · Kallestad Laboratories, Inc. · Sep 1981

MACRO-VUE CARD TEST

K810597 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981

FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY

K791596 · Bio-Rad · Oct 1979

QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO

K791502 · Bio-Rad · Sep 1979

AMES TDA/TOBRAMYCIN

K791435 · Miles Laboratories, Inc. · Aug 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K800743

Antibodies, Inc.

Mchenry, IL · US

Regulatory profile

16 submissions 16 cleared

100% clearance rate · Active in Toxicology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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