Riaphase (125I) Prost. Acid Phosph. Kit
FDA 510(k) K803043 · Beckman Instruments, Inc.
510(k) numberK803043
Submission
- Device name
- Riaphase (125I) Prost. Acid Phosph. Kit
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- December 1, 1980
- Decision date
- January 2, 1981
- 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
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| K981573 | Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia QuantitatveJFH · Traditional | United Biotech, Inc. | 09/15/1998SE |
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| K925377 | Imx PapJFH · Traditional | Abbott Laboratories | 01/13/1993SE |
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| 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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Questions and answers
When was Riaphase (125I) Prost. Acid Phosph. Kit cleared by the FDA?
Riaphase (125I) Prost. Acid Phosph. Kit (K803043) received a 510(k) decision of Substantially Equivalent on January 2, 1981, 32 days after the submission was received.
What is the product code of K803043?
The FDA product code is JFH – Acid Phosphatase (Prostatic), Tartrate Inhibited, a Class II (moderate risk) device regulated under 21 CFR 862.1020.