Prostatic Acid Phosphatase Reagent Test/Prostatic Acid Phosphatase Reagent Kit
FDA 510(k) K964756 · Wano-Tech Corp.
510(k) numberK964756
Submission
- Device name
- Prostatic Acid Phosphatase Reagent Test/Prostatic Acid Phosphatase Reagent Kit
- Applicant
- Wano-Tech Corp.
Belmont, CA, US - Received
- November 27, 1996
- Decision date
- April 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K884748 | Technicon Chem 1 System Acid Phos (Prostatic)JFH · Traditional | Technicon Instruments Corp. | 01/30/1989SE |
Questions and answers
When was Prostatic Acid Phosphatase Reagent Test/Prostatic Acid Phosphatase Reagent Kit cleared by the FDA?
Prostatic Acid Phosphatase Reagent Test/Prostatic Acid Phosphatase Reagent Kit (K964756) received a 510(k) decision of Substantially Equivalent on April 23, 1997, 147 days after the submission was received.
What is the product code of K964756?
The FDA product code is JFH – Acid Phosphatase (Prostatic), Tartrate Inhibited, a Class II (moderate risk) device regulated under 21 CFR 862.1020.