Estriol Ria Kit for Use with Gammaflo

Q: What is the product code of K801424?

The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.

FDA 510(k) K801424 · Squibb & Sons, Inc.

Substantially Equivalent

510(k) numberK801424

Submission

Device name: Estriol Ria Kit for Use with Gammaflo
Applicant: Squibb & Sons, Inc.
Walker, MI, US
Received: June 17, 1980
Decision date: July 21, 1980
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: CGI – Radioimmunoassay, Estriol
Device class: Class I (low risk)
Regulation: 21 CFR 862.1265
Specialty: Clinical Chemistry

Other 510(k)s with product code CGI

510(k)	Device	Applicant	Decision
K974721	Unconjugated Estriol Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System)CGI · Traditional	Bayer Corp.	03/03/1998SE
K962875	Active Ultrasensitive Unconjugated Estriol EiaCGI · Traditional	Diagnostic Systems Laboratories, Inc.	08/23/1996SE
K955356	Active Ultra-Sensitive Unconjugated EstriolCGI · Traditional	Diagnostic Systems Laboratories, Inc.	05/15/1996SE
K932989	Coat-A-Count Free EstriolCGI · Traditional	Diagnostic Products Corp.	12/19/1994SE
K944490	Autodelfia Unconjugated Estriol (UE3) KitCGI · Traditional	Wallac OY	12/09/1994SE
K920576	Amerlex-M High Sensitivity Unconjugated EstriolCGI · Traditional	Eastman Kodak Company	03/23/1992SE
K903359	Microzyme Unconjugated Estriol Enzyme Immuno KitCGI · Traditional	Immunotech Corp.	08/22/1990SE
K860900	Immpulse Free Estriol Assay ReagentsCGI · Traditional	Sclavo, Inc.	04/28/1986SE
K850787	Solid Phase Free Estriol Enzyme ImmunoassayCGI · Traditional	Nms Pharmaceuticals, Inc.	03/26/1985SE
K844767	Radioimmunoassay of Human Serum Plasma or Urine toCGI · Traditional	Biotecx Laboratories, Inc.	02/01/1985SE

More from Biotecx Laboratories, Inc.

510(k)	Device	Decision
K821174	Tsh-Squibb Radioimmunoassay KitJLW · Traditional	05/14/1982SE
K800750	Stomahesive Sterile WaferEXB · Traditional	05/08/1980SE
K770726	Ria Kit, T4 ClaspCDX · Traditional	04/28/1977SE
K761267	Angiotensin I Immutope KitCIB · Traditional	12/30/1976SE

Questions and answers

When was Estriol Ria Kit for Use with Gammaflo cleared by the FDA?

Estriol Ria Kit for Use with Gammaflo (K801424) received a 510(k) decision of Substantially Equivalent on July 21, 1980, 34 days after the submission was received.

What is the product code of K801424?

The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.