Elsa-Prol Immunoradiometric Assay Kit
FDA 510(k) K860823 · Cis-Us, Inc.
510(k) numberK860823
Submission
- Device name
- Elsa-Prol Immunoradiometric Assay Kit
- Applicant
- Cis-Us, Inc.
Lake Success, NY, US - Received
- March 4, 1986
- Decision date
- August 19, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFT – Radioimmunoassay, Prolactin (Lactogen)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1625
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971921 | Prolactin (PRL) Hormone Microplate ElisaCFT · Traditional | Monobind | 06/24/1997SE |
| K970281 | Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsCFT · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/25/1997SE |
| K970188 | Sealite Sciences, Inc. Aqualite ProlactinCFT · Traditional | Sealite Sciences, Inc. | 02/20/1997SE |
| K964748 | Elecsys Prolactin AssayCFT · Traditional | Boehringer Mannheim Corp. | 01/21/1997SE |
| K960561 | DSL Active Prolactin Elisa Model 10-4500CFT · Traditional | Diagnostic Systems Laboratories, Inc. | 04/26/1996SE |
| K960060 | DSL Active Prolactin IrmaCFT · Traditional | Diagnostic Systems Laboratories, Inc. | 02/29/1996SE |
| K954680 | Access Prolactin Assay (Modification)CFT · Traditional | Bio-Rad Laboratories, Inc. | 10/20/1995SE |
| K953656 | Abbott Imx Prolactin(Modification)CFT · Traditional | Abbott Mfg., Inc. | 10/03/1995SE |
| K953657 | Abbott Axsym Prolactin(Modification)CFT · Traditional | Abbott Mfg., Inc. | 09/25/1995SE |
| K944698 | Auraflex Prolactin 200 Test Pack, Calibrator Pack, Dilvent 1CFT · Traditional | Organon Teknika Corp. | 03/21/1995SE |
More from Organon Teknika Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K951708 | Elsa-HctJKR · Traditional | 09/05/1995SE |
| K950211 | Elsa-PthCEW · Traditional | 04/13/1995SE |
| K890799 | Curietron 192 High Dose RateJAQ · Traditional | 10/27/1989SE |
| K882449 | Cesium 137 Source, Model CSM-40IWI · Traditional | 04/14/1989SE |
| K871502 | Personnel Protective ShieldKPY · Traditional | 05/08/1987SE |
| K865027 | Irradiator for Biological Materials, IBL-137CMOT · Traditional | 02/26/1987SE |
| K863778 | Venticis IIIYT · Traditional | 10/27/1986SE |
| K860824 | Tshk-Nn Ria KitJLW · Traditional | 04/28/1986SE |
Questions and answers
When was Elsa-Prol Immunoradiometric Assay Kit cleared by the FDA?
Elsa-Prol Immunoradiometric Assay Kit (K860823) received a 510(k) decision of Substantially Equivalent on August 19, 1986, 168 days after the submission was received.
What is the product code of K860823?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.