Medix Biotech Prolactin Enzyme Immuno. Test Kit
FDA 510(k) K873355 · Medix Biotech, Inc.
510(k) numberK873355
Submission
- Device name
- Medix Biotech Prolactin Enzyme Immuno. Test Kit
- Applicant
- Medix Biotech, Inc.
Foster City, CA, US - Received
- August 20, 1987
- Decision date
- October 9, 1987
- 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 |
|---|---|---|
| K952873 | Medix Biotech Strep a Antigen Detection Test (Modification)GTZ · Traditional | 09/08/1995SE |
| K952319 | Contrast & Rapid HCG Urine/Serum TSTJHI · Traditional | 06/20/1995SE |
| K932482 | Medix Biotech Bestest Strep a Cat. No. BSF1010GTZ · Traditional | 07/18/1994SE |
| K932758 | Medix Biotech Bestest Hcg-Urine Test KitJHI · Traditional | 09/28/1993SE |
| K925436 | Medix Biotech Total T3 Enzyme Immunoassay Test KitCDP · Traditional | 12/28/1992SE |
| K924259 | Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100JHI · Traditional | 11/25/1992SE |
| K922047 | Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064DGC · Traditional | 08/05/1992SE |
| K921700 | TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093JLW · Traditional | 06/29/1992SE |
| K920712 | Medix Biotech Throxine Enzyme Immunoassay Test KitKLI · Traditional | 03/27/1992SE |
| K920345 | Prolactin Enzyme Immunoassay Test Kit (Modified)CFT · Traditional | 03/18/1992SE |
Questions and answers
When was Medix Biotech Prolactin Enzyme Immuno. Test Kit cleared by the FDA?
Medix Biotech Prolactin Enzyme Immuno. Test Kit (K873355) received a 510(k) decision of Substantially Equivalent on October 9, 1987, 50 days after the submission was received.
What is the product code of K873355?
The FDA product code is CFT – Radioimmunoassay, Prolactin (Lactogen), a Class I (low risk) device regulated under 21 CFR 862.1625.