I-Estriol Test Set
FDA 510(k) K781599 · Wien Laboratories, Inc.
510(k) numberK781599
Submission
- Device name
- I-Estriol Test Set
- Applicant
- Wien Laboratories, Inc.
Mchenry, IL, US - Received
- September 18, 1978
- Decision date
- October 17, 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K912850 | SHBGCDZ · Traditional | 08/12/1991SE |
| K834246 | Progesterone Test Set 125I 17-OHJLX · Traditional | 02/04/1984SE |
| K832452 | Androstenedione Test Set 125ICIZ · Traditional | 09/12/1983SE |
| K823200 | 125 I-Dehydroepiandrosterone SulfateJKC · Traditional | 11/29/1982SE |
| K821653 | Protriptyline Tri-Cy Test SetLFG · Traditional | 06/14/1982SE |
| K821652 | Doxepin Tri-Cy Test SetLFG · Traditional | 06/14/1982SE |
| K802728 | 125I-TESTOSTERONE Test SetCDZ · Traditional | 12/11/1980SE |
| K792041 | Dhea-Sulfate Test SetJKC · Traditional | 10/30/1979SE |
| K781834 | Test Set, 125 I-DigoxinDNL · Traditional | 01/03/1979SE |
| K772306 | 125I Digoxin Test SetDPB · Traditional | 12/22/1977SE |
Questions and answers
When was I-Estriol Test Set cleared by the FDA?
I-Estriol Test Set (K781599) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 29 days after the submission was received.
What is the product code of K781599?
The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.