Prolactin (PRL) Hormone Microplate Elisa
FDA 510(k) K971921 · Monobind
510(k) numberK971921
Submission
- Device name
- Prolactin (PRL) Hormone Microplate Elisa
- Applicant
- Monobind
Costa Mesa, CA, US - Received
- May 23, 1997
- Decision date
- June 24, 1997
- 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 |
|---|---|---|---|
| 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 |
| K943811 | Enzyme-Linked Fluorescent ImmunoassayCFT · Traditional | Biomerieux Vitek, Inc. | 11/02/1994SE |
More from Biomerieux Vitek, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K181017 | Free Testosterone AccuBind ELISA Test SystemCDZ · Traditional | 07/20/2018SE |
| K063437 | Accubind Neo-Tsh Microwell Elisa, Model 3425-300JLW · Traditional | 04/04/2008SE |
| K030860 | Accubind Neonatal T4 Microplate Eia, Model 2625-300KLI · Traditional | 08/22/2003SE |
| K020548 | Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300CEC · Traditional | 04/05/2002SE |
| K980088 | T-Uptake Microplate EiaKHQ · Traditional | 02/04/1998SE |
| K972720 | Follicle Stimulating Hormone (FSH) Microplate Elisa (425-300)CGJ · Traditional | 09/02/1997SE |
| K971835 | Anti-Thyroglobulin (TG) Microplate ElisaDDC · Traditional | 07/03/1997SE |
| K971834 | Anti-Thyroid Peroxidase (Tpo) Microplate ElisaJNL · Traditional | 07/03/1997SE |
| K971780 | Thyrotropin(Tsh) ElisaJLW · Traditional | 06/24/1997SE |
| K971779 | Total TRIIODOTHYRONINE(T3) Microplate EiaCDP · Traditional | 06/16/1997SE |
Questions and answers
When was Prolactin (PRL) Hormone Microplate Elisa cleared by the FDA?
Prolactin (PRL) Hormone Microplate Elisa (K971921) received a 510(k) decision of Substantially Equivalent on June 24, 1997, 32 days after the submission was received.
What is the product code of K971921?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.