Ciba Corning Magic Lite Prolactin Immunoassay
FDA 510(k) K894988 · Ciba Corning Diagnostics Corp.
510(k) numberK894988
Submission
- Device name
- Ciba Corning Magic Lite Prolactin Immunoassay
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- August 8, 1989
- Decision date
- October 12, 1989
- 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 |
|---|---|---|
| K962559 | Acs Cortisol ImmunoassayJFT · Traditional | 11/05/1996SE |
| K963251 | Ciba Corning ACS;180 DPD AssayJMM · Traditional | 10/15/1996SE |
| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | 07/26/1996SE |
| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
| K962021 | Ciba Corning 348 SystemCHL · Traditional | 06/24/1996SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | 06/21/1996SE |
| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
Questions and answers
When was Ciba Corning Magic Lite Prolactin Immunoassay cleared by the FDA?
Ciba Corning Magic Lite Prolactin Immunoassay (K894988) received a 510(k) decision of Substantially Equivalent on October 12, 1989, 65 days after the submission was received.
What is the product code of K894988?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.