Product Code: DNN FDA class 2 21 CFR 862.3200

Calibrators, Ethyl Alcohol

Clinical Toxicology

Ethyl Alcohol Calibrators are reference standards used in clinical toxicology laboratories to calibrate analytical instruments measuring ethanol concentrations in patient specimens, ensuring accurate and reproducible results. This is a Class 2 device requiring 510(k) premarket notification. The product code is DNN, regulated under 21 CFR 862.3200, within the Clinical Toxicology specialty. No special regulatory flags apply.

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510(k)s

FEI Numbers

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Basic Information

Product Code: DNN
Device Class: FDA class 2
Regulation Number: 862.3200
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 7 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K990516	ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS	Mar 31, 1999	Substantially Equivalent	Emd Chemicals, Inc.
K973054	ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS	Oct 01, 1997	Substantially Equivalent	Emd Chemicals, Inc.
K924733	ETHYL ALCOHOL CALIBRATORS & CONTROL	Dec 09, 1992	Substantially Equivalent	Diagnostic Reagents, Inc.
K882117	ETHYL ALCOHOL STANDARD	Aug 04, 1988	Substantially Equivalent	Verichem Laboratories, Inc.
K853532	ALCOHOL CALIBRATORS	Sep 16, 1985	Substantially Equivalent	Diagnostic Systems
K810466	ETHYL ALCOHOL SERUM CALIBRATOR	Mar 06, 1981	Substantially Equivalent	Syva Co.
K802620	EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR	Oct 31, 1980	Substantially Equivalent	Syva Co.