Prolactin Irma
FDA 510(k) K842478 · Euro-Diagnostics BV
510(k) numberK842478
Submission
- Device name
- Prolactin Irma
- Applicant
- Euro-Diagnostics BV
Mchenry, IL, US - Received
- June 25, 1984
- Decision date
- September 14, 1984
- 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 |
|---|---|---|
| K851332 | Blhi Luteinizing HormoneCEP · Traditional | 07/09/1985SE |
| K851148 | TSH IRMA(125I) Btsi 1(THYROID Stimula-HormoneJLW · Traditional | 04/29/1985SE |
| K850053 | Baci 6 -Adrenocorticotroop HormoneCKG · Traditional | 04/08/1985SE |
| K843930 | Irma Immunoradiometric Assay-Fsh 125ICGJ · Traditional | 10/30/1984SE |
Questions and answers
When was Prolactin Irma cleared by the FDA?
Prolactin Irma (K842478) received a 510(k) decision of Substantially Equivalent on September 14, 1984, 81 days after the submission was received.
What is the product code of K842478?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.