510(k) K823504
- Device
- CYCLIC ADENOSINE MONOPHOSHATE BY RADIO
- Applicant
- IMMUNO NUCLEAR CORP.
- 510(k) number
- K823504
- Product code
- CHO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-28
- Date received
- 1982-11-24
- Regulation
- 862.1230
- Classification name
- Radioimmunoassay, Cyclic Amp
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CHO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K860253 | AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) | Amersham Corp. | 1986-03-14 |
| K844135 | PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU | Immuno Nuclear Corp. | 1985-03-05 |
| K841478 | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY | New England Nuclear | 1984-06-14 |
| K811746 | KING DIAGNOSTICS CHOLESTEROL-FE TEST | King Diagnostics, Inc. | 1981-07-10 |
| K811273 | CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-05-27 |
Legacy Summary#
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FDA Review#
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