Ria Kit, Quantitation of Prostatic Acid
FDA 510(k) K790817 · New England Nuclear
510(k) numberK790817
Submission
- Device name
- Ria Kit, Quantitation of Prostatic Acid
- Applicant
- New England Nuclear
Mchenry, IL, US - Received
- April 27, 1979
- Decision date
- May 7, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFH – Acid Phosphatase (Prostatic), Tartrate Inhibited
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1020
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000257 | Immulite 2000 Pap, Models L2KPA2, L2KPA6JFH · Traditional | Diagnostic Products Corp. | 02/23/2000SE |
| K981573 | Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia QuantitatveJFH · Traditional | United Biotech, Inc. | 09/15/1998SE |
| K964756 | Prostatic Acid Phosphatase Reagent Test/Prostatic Acid Phosphatase Reagent KitJFH · Traditional | Wano-Tech Corp. | 04/23/1997SE |
| K931701 | Immulite PapJFH · Traditional | Diagnostic Products Corp. | 01/27/1994SE |
| K925377 | Imx PapJFH · Traditional | Abbott Laboratories | 01/13/1993SE |
| K921745 | Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional | Hybritech, Inc. | 07/30/1992SE |
| K902937 | Milenia Pap Irma Catalog #: MKPA1, XJFH · Traditional | Diagnostic Products Corp. | 09/21/1990SE |
| K901933 | Coat-A-Count Pap Irma, Catlog# 1KPA1, 1KPA2JFH · Traditional | Diagnostic Products Corp. | 06/28/1990SE |
| K895723 | Irma-Count(Tm) Pap, (RKPA1, RKPA2)JFH · Traditional | Diagnostic Products Corp. | 10/31/1989SE |
| K893508 | Prostate Specific Antigen Immunohistochemical AntiJFH · Traditional | Baxter Healthcare Corp | 08/04/1989SE |
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| K834038 | Rianen Follicle Stimulating HormoneCGJ · Traditional | 01/30/1984SE |
| K833376 | Rianen Luteinizing Hormone Ria KitCEP · Traditional | 12/20/1983SE |
| K831345 | Rianen Prolactin 125I KitCFT · Traditional | 06/08/1983SE |
| K801245 | Atomlight (Liquid Scintillation SolutionJJJ · Traditional | 06/20/1980SE |
| K792175 | Rianen, Vitamin B12 Assay SystemCDD · Traditional | 11/13/1979SE |
| K782110 | Ria Kit, Rianen CortisolCGR · Traditional | 01/26/1979SE |
| K781888 | Assay System, Ferritin I KitJMG · Traditional | 01/10/1979SE |
| K781495 | Rianen Assay System, 125I KitDNL · Traditional | 09/14/1978SE |
Questions and answers
When was Ria Kit, Quantitation of Prostatic Acid cleared by the FDA?
Ria Kit, Quantitation of Prostatic Acid (K790817) received a 510(k) decision of Substantially Equivalent on May 7, 1979, 10 days after the submission was received.
What is the product code of K790817?
The FDA product code is JFH – Acid Phosphatase (Prostatic), Tartrate Inhibited, a Class II (moderate risk) device regulated under 21 CFR 862.1020.