Human Follicle Stimulating Hormone
FDA 510(k) K780016 · Pcl-Ria, Inc.
510(k) numberK780016
Submission
- Device name
- Human Follicle Stimulating Hormone
- Applicant
- Pcl-Ria, Inc.
Mchenry, IL, US - Received
- January 3, 1978
- Decision date
- February 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K830526 | B-Gcg System by RiaJHI · Traditional | 04/05/1983SE |
| K823014 | Digoxin KitDPB · Traditional | 11/01/1982SE |
| K822935 | Thyroid Stimulating HormoneJLW · Traditional | 11/01/1982SE |
| K822612 | T3 Uptake KitsKHQ · Traditional | 09/30/1982SE |
| K820886 | Thyroxine T4 KitCDX · Traditional | 04/16/1982SE |
| K820358 | Follicle Stimulating Hormone KitCGJ · Traditional | 03/26/1982SE |
| K820357 | Luteinizing Hormone KitCEP · Traditional | 03/25/1982SE |
| K812666 | Thyroxine (T4) 125ICDP · Traditional | 10/02/1981SE |
| K810867 | Follicle Stimulating Hormone (FSH)JIS · Traditional | 04/14/1981SE |
| K810852 | Follicle Stimulating Hormone AntiserumCGJ · Traditional | 04/08/1981SE |
Questions and answers
When was Human Follicle Stimulating Hormone cleared by the FDA?
Human Follicle Stimulating Hormone (K780016) received a 510(k) decision of Substantially Equivalent on February 3, 1978, 31 days after the submission was received.
What is the product code of K780016?
The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.