DSL 1900
FDA 510(k) K830816 · Diagnostic Systems
510(k) numberK830816
Submission
- Device name
- DSL 1900
- Applicant
- Diagnostic Systems
Mchenry, IL, US - Received
- March 15, 1983
- Decision date
- April 12, 1983
- 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 |
|---|---|---|
| K905146 | Olympus Urine PHJQY · Traditional | 02/04/1991SE |
| K893691 | Emds Creatine Kinase Item Nimber 65411CGS · Traditional | 08/31/1989SE |
| K893692 | Emds Aspartate Aminotransferase Item Number 65405CIT · Traditional | 08/21/1989SE |
| K893966 | HDL Precipitating ReagentLBR · Traditional | 07/25/1989SE |
| K884993 | Visual Blood Glucose Test SystemCGA · Traditional | 12/29/1988SE |
| K881116 | Easy-Test Emit(R) Lidocaine Lido Item No. 16641KLR · Traditional | 06/20/1988SE |
| K880787 | Easy-Test Lactic Acid (la)KHP · Traditional | 03/15/1988SE |
| K862403 | Emds Antiepileptic Drug Calibrators Item #67630/95DKB · Traditional | 07/11/1986SE |
| K854784 | Absorbance (Abs) Test PakJIT · Traditional | 12/19/1985SE |
| K853699 | Easy Analyzer & Easy-Test ReagentJJE · Traditional | 09/25/1985SE |
Questions and answers
When was DSL 1900 cleared by the FDA?
DSL 1900 (K830816) received a 510(k) decision of Substantially Equivalent on April 12, 1983, 28 days after the submission was received.
What is the product code of K830816?
The FDA product code is CGI – Radioimmunoassay, Estriol, a Class I (low risk) device regulated under 21 CFR 862.1265.