AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)
FDA 510(k) clearance K860253 · decided 1986-03-14
Clearance details
- K-number
- K860253
- Device name
- AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)
- Applicant
- Amersham Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-24
- Decision date
- 1986-03-14
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- CHO
- Device class
- 2
- Regulation number
- 862.1230
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Arlington Heights, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU (K844135) | Immuno Nuclear Corp. | 1985-03-05 |
| RIANEN CYCLIC-AMP RADIOIMMUNOASSAY (K841478) | New England Nuclear | 1984-06-14 |
| CYCLIC ADENOSINE MONOPHOSHATE BY RADIO (K823504) | Immuno Nuclear Corp. | 1983-01-28 |
| KING DIAGNOSTICS CHOLESTEROL-FE TEST (K811746) | King Diagnostics, Inc. | 1981-07-10 |
| CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] (K811273) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-05-27 |
Recalls involving this device
No recalls on record reference this clearance.