Access Prolactin
FDA 510(k) K941175 · Bio-Rad Laboratories, Inc.
510(k) numberK941175
Submission
- Device name
- Access Prolactin
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- March 14, 1994
- Decision date
- June 2, 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 |
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Questions and answers
When was Access Prolactin cleared by the FDA?
Access Prolactin (K941175) received a 510(k) decision of Substantially Equivalent on June 2, 1994, 80 days after the submission was received.
What is the product code of K941175?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.