510(k) K811273
- Device
- CYCLIC AMP RADIOIMMUNOASSAY KIT [125I]
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K811273
- Product code
- CHO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-27
- Date received
- 1981-05-07
- 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
- 4221 Richmond Rd., NW Walker MI US 49534 49534
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 |
| K823504 | CYCLIC ADENOSINE MONOPHOSHATE BY RADIO | Immuno Nuclear Corp. | 1983-01-28 |
| K811746 | KING DIAGNOSTICS CHOLESTEROL-FE TEST | King Diagnostics, Inc. | 1981-07-10 |
Legacy Summary#
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FDA Review#
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