Diagnostic Radioimmunoassay for Quanti
FDA 510(k) K822298 · Nuclear Medical Laboratories, Inc.
510(k) numberK822298
Submission
- Device name
- Diagnostic Radioimmunoassay for Quanti
- Applicant
- Nuclear Medical Laboratories, Inc.
Mchenry, IL, US - Received
- August 3, 1982
- Decision date
- September 2, 1982
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K852438 | NML TSH IrmaJLW · Traditional | 07/12/1985SE |
| K844583 | Tsh-StatJLW · Traditional | 03/05/1985SE |
| K840466 | NML Cortisol RiaCGR · Traditional | 03/30/1984SE |
| K840589 | Tri-Tube RiaKHQ · Traditional | 03/09/1984SE |
| K832892 | Modified Chorio-ShureJHI · Traditional | 10/28/1983SE |
| K832002 | NML-5010/5020 Multi-Detector SystemJJJ · Traditional | 08/08/1983SE |
| K823679 | NML 6000 CTJQP · Traditional | 01/07/1983SE |
| K823053 | Nml-Tetra-Tube RiaCDX · Traditional | 11/10/1982SE |
| K820523 | Chorio-QuantJHI · Traditional | 03/15/1982SE |
| K812759 | NML Ck-Mb RiaJHX · Traditional | 10/19/1981SE |
Questions and answers
When was Diagnostic Radioimmunoassay for Quanti cleared by the FDA?
Diagnostic Radioimmunoassay for Quanti (K822298) received a 510(k) decision of Substantially Equivalent on September 2, 1982, 30 days after the submission was received.
What is the product code of K822298?
The FDA product code is JFH – Acid Phosphatase (Prostatic), Tartrate Inhibited, a Class II (moderate risk) device regulated under 21 CFR 862.1020.