Dupont Aca Plus Prolactin (Prol) Method
FDA 510(k) K941220 · Dupont Medical Products
510(k) numberK941220
Submission
- Device name
- Dupont Aca Plus Prolactin (Prol) Method
- Applicant
- Dupont Medical Products
Wilmington, DE, US - Received
- March 14, 1994
- Decision date
- June 3, 1994
- 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 |
| 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 |
|---|---|---|
| K952815 | Dupont Lipase CalibratorJIT · Traditional | 08/31/1995SE |
| K950920 | Dupont Dimension Total Protein MethodCEK · Traditional | 08/11/1995SE |
| K952816 | Lipase Flex Reagent CartridgeCHI · Traditional | 07/20/1995SE |
| K952412 | Dupont Aca(R) Urine Druge Os Abuse ControlDIF · Traditional | 06/23/1995SE |
| K945280 | Dupont Dimension C-Reactive Protein MethodDCK · Traditional | 03/09/1995SE |
| K944932 | Phenobarbital Flex Reagent CartridgeDLZ · Traditional | 12/28/1994SE |
| K941050 | Dupont Aca StarJJQ · Traditional | 11/10/1994SE |
| K943996 | Dupont Aca Plus Luteinizing Hormone (LH) MethodCEP · Traditional | 10/20/1994SE |
| K941146 | Dupont Aca Plus Thyroid Stimulating Hormone SystemJLW · Traditional | 10/03/1994SE |
| K942640 | Dupont Dimension Amylase MethodJFJ · Traditional | 09/09/1994SE |
Questions and answers
When was Dupont Aca Plus Prolactin (Prol) Method cleared by the FDA?
Dupont Aca Plus Prolactin (Prol) Method (K941220) received a 510(k) decision of Substantially Equivalent on June 3, 1994, 81 days after the submission was received.
What is the product code of K941220?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.