Active Ultra-Sensitive Unconjugated Estriol
FDA 510(k) K955356 · Diagnostic Systems Laboratories, Inc.
510(k) numberK955356
Submission
- Device name
- Active Ultra-Sensitive Unconjugated Estriol
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- November 21, 1995
- Decision date
- May 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGI – Radioimmunoassay, Estriol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1265
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| 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 |
| 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 |
| K844511 | TDX Total EstriolCGI · Traditional | Abbott Laboratories | 01/18/1985SE |
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Questions and answers
When was Active Ultra-Sensitive Unconjugated Estriol cleared by the FDA?
Active Ultra-Sensitive Unconjugated Estriol (K955356) received a 510(k) decision of Substantially Equivalent on May 15, 1996, 176 days after the submission was received.
What is the product code of K955356?
The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.