Plasma Cyclic Adenosine Monophosphate by Radioimmu
FDA 510(k) K844135 · Immuno Nuclear Corp.
510(k) numberK844135
Submission
- Device name
- Plasma Cyclic Adenosine Monophosphate by Radioimmu
- Applicant
- Immuno Nuclear Corp.
Stillwater, MN, US - Received
- October 23, 1984
- Decision date
- March 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHO – Radioimmunoassay, Cyclic Amp
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1230
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K860253 | Amerlex-M CAMP(125)ASSAY System RPA.508 (100 Kit)CHO · Traditional | Amersham Corp. | 03/14/1986SE |
| K841478 | Rianen Cyclic-Amp RadioimmunoassayCHO · Traditional | New England Nuclear | 06/14/1984SE |
| K823504 | Cyclic Adenosine Monophoshate by RadioCHO · Traditional | Immuno Nuclear Corp. | 01/28/1983SE |
| K811746 | King Diagnostics Cholesterol-Fe TestCHO · Traditional | King Diagnostics, Inc. | 07/10/1981SE |
| K811273 | Cyclic Amp Radioimmunoassay Kit [125I]CHO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/27/1981SE |
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| K863123 | Immuno Biotech Mugwart Allergen DiscDHB · Traditional | 10/01/1986SE |
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| K862266 | Maple Allergen DiscDHB · Traditional | 08/19/1986SE |
| K862939 | Orchard Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862938 | June Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862265 | Cottonwood Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862176 | Russian Thistle Allergen DiscDHB · Traditional | 08/15/1986SE |
Questions and answers
When was Plasma Cyclic Adenosine Monophosphate by Radioimmu cleared by the FDA?
Plasma Cyclic Adenosine Monophosphate by Radioimmu (K844135) received a 510(k) decision of Substantially Equivalent on March 5, 1985, 133 days after the submission was received.
What is the product code of K844135?
The FDA product code is CHO – Radioimmunoassay, Cyclic Amp, a Class II (moderate risk) device regulated under 21 CFR 862.1230.