Cleared Traditional

K904764 - EMIT II CALIBRATOR A LEVEL 1 (CUTOFF) 2...

K904764 is the FDA 510(k) clearance for EMIT II CALIBRATOR A LEVEL 1 (CUTOFF) 2... by Syva Co.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K904764 · Syva Co. · Toxicology device
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Nov 1990
Decision
29d
Days
Class 2
Risk

K904764 is an FDA 510(k) clearance for the EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH). Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on November 20, 1990 after a review of 29 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 Syva Co. devices

Submission Details

510(k) Number K904764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1990
Decision Date November 20, 1990
Days to Decision 29 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
58d faster than avg
Panel avg: 87d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
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 - DKB Calibrators, Drug Mixture

All 75
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K904764.
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
K910085 · Roche Diagnostic Systems, Inc. · Mar 1991
ABUSCREEN(R) ONLINE CALIBRATORS
K905828 · Roche Diagnostic Systems, Inc. · Feb 1991
ABUSCREEN ONLINE OPIATES CALIBRATORS
K910087 · Roche Diagnostic Systems, Inc. · Feb 1991
EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS
K903152 · Syva Co. · Aug 1990
EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
K902581 · Syva Co. · Jul 1990
EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2
K902578 · Syva Co. · Jul 1990