Abbott Axsym Prolactin(Modification)
FDA 510(k) K953657 · Abbott Mfg., Inc.
510(k) numberK953657
Submission
- Device name
- Abbott Axsym Prolactin(Modification)
- Applicant
- Abbott Mfg., Inc.
Abbott Park, IL, US - Received
- July 18, 1995
- Decision date
- September 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K944698 | Auraflex Prolactin 200 Test Pack, Calibrator Pack, Dilvent 1CFT · Traditional | Organon Teknika Corp. | 03/21/1995SE |
| K943811 | Enzyme-Linked Fluorescent ImmunoassayCFT · Traditional | Biomerieux Vitek, Inc. | 11/02/1994SE |
More from Biomerieux Vitek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981457 | AlbpCJW · Traditional | 05/27/1998SE |
| K981232 | CaCJY · Traditional | 05/18/1998SE |
| K981231 | CO2KHS · Traditional | 05/12/1998SE |
| K965230 | Abbott Lifecare Standard Tubing Infusion PumpFRN · Traditional | 07/03/1997SE |
| K971293 | Lifeshield Primary I.V. Set with Backcheck ValveFPA · Traditional | 06/27/1997SE |
| K953656 | Abbott Imx Prolactin(Modification)CFT · Traditional | 10/03/1995SE |
| K944669 | Flexiflo Quantum Enteral PumpFRN · Traditional | 07/24/1995SE |
| K943691 | Imx FolateCGN · Traditional | 03/23/1995SE |
| K943733 | Flexiflo Six Enteral Nutrition PumpLZH · Traditional | 12/12/1994ST |
| K941214 | Lifeshield Extension SetFPK · Traditional | 10/03/1994SE |
Questions and answers
When was Abbott Axsym Prolactin(Modification) cleared by the FDA?
Abbott Axsym Prolactin(Modification) (K953657) received a 510(k) decision of Substantially Equivalent on September 25, 1995, 69 days after the submission was received.
What is the product code of K953657?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.