Prostatic Acid Phosphatase (Pap) Rda Kit
FDA 510(k) K811169 · Amersham Corp.
510(k) numberK811169
Submission
- Device name
- Prostatic Acid Phosphatase (Pap) Rda Kit
- Applicant
- Amersham Corp.
Mchenry, IL, US - Received
- April 28, 1981
- Decision date
- May 15, 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
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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| K912733 | Amerlex-M Specific Estrol(Unconjugated) Ria KitCIG · Traditional | 07/22/1991SE |
| K912766 | Amerlite Ck-Mb AssayJHY · Traditional | 07/17/1991SE |
| K904666 | Amerlite TSH-60 Assay Product Code: Lan. 0008/2008JLW · Traditional | 11/02/1990SE |
| K902760 | Amersham TSH Control SeraJJX · Traditional | 07/27/1990SE |
| K901857 | GADOLINIUM-153 Bone Densitometer (GDC.10413)KGI · Traditional | 07/09/1990SE |
| K901854 | GADOLINIUM-153 Bone Densitometer (GDC.10411/10412)KGI · Traditional | 07/09/1990SE |
| K901848 | GADOLINIUM-153 Bone Densitometer SourcesKGI · Traditional | 07/09/1990SE |
| K901832 | GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional | 07/09/1990SE |
| K896270 | Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional | 12/12/1989SE |
Questions and answers
When was Prostatic Acid Phosphatase (Pap) Rda Kit cleared by the FDA?
Prostatic Acid Phosphatase (Pap) Rda Kit (K811169) received a 510(k) decision of Substantially Equivalent on May 15, 1981, 17 days after the submission was received.
What is the product code of K811169?
The FDA product code is JFH – Acid Phosphatase (Prostatic), Tartrate Inhibited, a Class II (moderate risk) device regulated under 21 CFR 862.1020.