Fluoromatic Phenolbarbital Fia

FDA 510(k) K800090 · Bio-Rad

Substantially Equivalent

510(k) numberK800090

Submission

Device name
Fluoromatic Phenolbarbital Fia
Applicant
Bio-Rad
Mchenry, IL, US
Received
January 14, 1980
Decision date
January 23, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DKP – Radioimmunoassay, Phenobarbital
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3660
Specialty
Clinical Toxicology

Other 510(k)s with product code DKP

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K844167Aria HT Phenobarbital Radioimmunoassay KitDKP · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic11/27/1984SE
K772111In Vitro Phenobarbital Ria TestDKP · Traditional Clinical Assays, Inc.11/28/1977SE

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Questions and answers

When was Fluoromatic Phenolbarbital Fia cleared by the FDA?

Fluoromatic Phenolbarbital Fia (K800090) received a 510(k) decision of Substantially Equivalent on January 23, 1980, 9 days after the submission was received.

What is the product code of K800090?

The FDA product code is DKP – Radioimmunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.