Ria Kit, Prolactin
FDA 510(k) K790003 · Cis Radiopharmaceuticals, Inc.
510(k) numberK790003
Submission
- Device name
- Ria Kit, Prolactin
- Applicant
- Cis Radiopharmaceuticals, Inc.
Mchenry, IL, US - Received
- January 2, 1979
- Decision date
- March 12, 1979
- 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 |
|---|---|---|
| K791860 | Ferritin Ria KitDBF · Traditional | 12/06/1979SE |
| K792063 | Follicle Stimulating Hormone (FSH) KitCGJ · Traditional | 11/20/1979SE |
| K791202 | Ria Kit for TrypsinJNO · Traditional | 11/05/1979SE |
| K792000 | Luteinizing Hormone (LH) RiaCEP · Traditional | 10/30/1979SE |
| K791051 | Progesterone Radioimmunoassay KitJLS · Traditional | 07/24/1979SE |
| K780982 | Kits, Ria, Myoglobin, Human, MeasurementDDR · Traditional | 06/22/1978SE |
| K771878 | Iridium 192 Wires & PinsIWA · Traditional | 10/27/1977SE |
| K760251 | Set, Oral AdministrationLEY · Traditional | 09/15/1976SE |
Questions and answers
When was Ria Kit, Prolactin cleared by the FDA?
Ria Kit, Prolactin (K790003) received a 510(k) decision of Substantially Equivalent on March 12, 1979, 69 days after the submission was received.
What is the product code of K790003?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.