Coat-A-Count Morphine Kit & Components

FDA 510(k) K823680 · Diagnostic Products Corp.

Substantially Equivalent

510(k) numberK823680

Submission

Device name
Coat-A-Count Morphine Kit & Components
Applicant
Diagnostic Products Corp.
Walker, MI, US
Received
December 7, 1982
Decision date
January 5, 1983
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)DeviceApplicantDecision
K902055Tenone(Tm) Opiates Catalog: VKSO1,4DDE · Traditional Diagnostic Products Corp.07/10/1990SE
K820900Emit Urine Methadone Assay #3E319DDE · Traditional Syva Co.04/26/1982SE

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Questions and answers

When was Coat-A-Count Morphine Kit & Components cleared by the FDA?

Coat-A-Count Morphine Kit & Components (K823680) received a 510(k) decision of Substantially Equivalent on January 5, 1983, 29 days after the submission was received.

What is the product code of K823680?

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