Emit Urine Methadone Assay #3E319

Q: What is the product code of K820900?

The FDA product code is DDE – Carbonic Anhydrase C, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5200.

FDA 510(k) K820900 · Syva Co.

Substantially Equivalent

510(k) numberK820900

Submission

Device name: Emit Urine Methadone Assay #3E319
Applicant: Syva Co.
Mchenry, IL, US
Received: March 31, 1982
Decision date: April 26, 1982
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DDE – Carbonic Anhydrase C, Antigen, Antiserum, Control
Device class: Class I (low risk)
Regulation: 21 CFR 866.5200
Specialty: Immunology

Other 510(k)s with product code DDE

510(k)	Device	Applicant	Decision
K902055	Tenone(Tm) Opiates Catalog: VKSO1,4DDE · Traditional	Diagnostic Products Corp.	07/10/1990SE
K823680	Coat-A-Count Morphine Kit & ComponentsDDE · Traditional	Diagnostic Products Corp.	01/05/1983SE

More from Diagnostic Products Corp.

510(k)	Device	Decision
K011878	Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional	08/13/2001SE
K012257	Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229DKZ · Special	08/03/2001SE
K011947	Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special	07/02/2001SE
K011528	Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special	06/06/2001SE
K011347	Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special	05/17/2001SE
K993981	Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional	02/01/2000SE
K993980	Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional	02/01/2000SE
K993988	Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional	01/27/2000SE
K993987	Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional	01/27/2000SE
K993986	Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional	01/27/2000SE

Questions and answers

When was Emit Urine Methadone Assay #3E319 cleared by the FDA?

Emit Urine Methadone Assay #3E319 (K820900) received a 510(k) decision of Substantially Equivalent on April 26, 1982, 26 days after the submission was received.

What is the product code of K820900?

The FDA product code is DDE – Carbonic Anhydrase C, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5200.