Microzyme Unconjugated Estriol Enzyme Immuno Kit
FDA 510(k) K903359 · Immunotech Corp.
510(k) numberK903359
Submission
- Device name
- Microzyme Unconjugated Estriol Enzyme Immuno Kit
- Applicant
- Immunotech Corp.
Boston, MA, US - Received
- July 25, 1990
- Decision date
- August 22, 1990
- 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 |
| 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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|---|---|---|
| K954188 | Opticlone IGG1 FITC/IGG2A Pe Isotypic ControlGKZ · Traditional | 11/03/1995SE |
| K946335 | Opticlone(Tm CD3 FITC/CD19 Pe Monoclonal AntibodiesGKZ · Traditional | 10/20/1995SE |
| K953498 | Opticlone IGG1 FITC/IGG1 Pe Isotypic ControlGKZ · Traditional | 09/08/1995SE |
| K952789 | Opticlone CD4FITC/CD8 Pe Monoclonal AntibodiesGKZ · Traditional | 08/14/1995SE |
| K952182 | Opticlone CD3/CD8 Monoclonal AntibodiesGKZ · Traditional | 07/05/1995SE |
| K950626 | Opticlone CD3/CD4 Monoclonal AntibodiesGKZ · Traditional | 05/05/1995SE |
| K931228 | Progesterone Radioimmunoassay KitJLS · Traditional | 10/22/1993SE |
| K911634 | Microzyme(Tm) Free T4 Enzyme Immunoassay TestCEC · Traditional | 06/24/1991SE |
| K911153 | Microzyme Phencyclidine Enzyme Immunoassay Test KTLCM · Traditional | 06/18/1991SE |
| K910411 | Microzyme TSH Enzyme Immunoassay KitJLW · Traditional | 04/03/1991SE |
Questions and answers
When was Microzyme Unconjugated Estriol Enzyme Immuno Kit cleared by the FDA?
Microzyme Unconjugated Estriol Enzyme Immuno Kit (K903359) received a 510(k) decision of Substantially Equivalent on August 22, 1990, 28 days after the submission was received.
What is the product code of K903359?
The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.