Cyclic Amp Radioimmunoassay Kit [125I]
FDA 510(k) K811273 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK811273
Submission
- Device name
- Cyclic Amp Radioimmunoassay Kit [125I]
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Walker, MI, US - Received
- May 7, 1981
- Decision date
- May 27, 1981
- 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 |
| K844135 | Plasma Cyclic Adenosine Monophosphate by RadioimmuCHO · Traditional | Immuno Nuclear Corp. | 03/05/1985SE |
| 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 |
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Questions and answers
When was Cyclic Amp Radioimmunoassay Kit [125I] cleared by the FDA?
Cyclic Amp Radioimmunoassay Kit [125I] (K811273) received a 510(k) decision of Substantially Equivalent on May 27, 1981, 20 days after the submission was received.
What is the product code of K811273?
The FDA product code is CHO – Radioimmunoassay, Cyclic Amp, a Class II (moderate risk) device regulated under 21 CFR 862.1230.