Cleared Traditional

K893506 - INNOFLUOR CARBAMAZEPINE CALIBRATOR SET

K893506 is the FDA 510(k) clearance for INNOFLUOR CARBAMAZEPINE CALIBRATOR SET by Innotron of Oregon, Inc.. It is a Class 2 Chemistry device (product code DLJ) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K893506 · Innotron of Oregon, Inc. · Chemistry device
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Aug 1989
Decision
102d
Days
Class 2
Risk

K893506 is an FDA 510(k) clearance for the INNOFLUOR CARBAMAZEPINE CALIBRATOR SET. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - 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 Innotron of Oregon, Inc. devices

Submission Details

510(k) Number K893506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1989
Decision Date August 15, 1989
Days to Decision 102 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 88d · This submission: 102d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 94
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K893506.
DUPONT SALICYLATE CALIBRATOR
K904307 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1990
DUPONT DRUG CLIBRATOR-B
K904303 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
DUPONT ALCOHOL CALIBRATOR
K904308 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
ACA VANCOMYCIN CALIBRATOR
K892901 · E.I. Dupont DE Nemours & Co., Inc. · May 1989
EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR
K890451 · Syva Co. · Feb 1989
EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR
K890452 · Syva Co. · Feb 1989