RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
FDA 510(k) clearance K850054 · decided 1985-03-29
Clearance details
- K-number
- K850054
- Device name
- RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-08
- Decision date
- 1985-03-29
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- CIB
- Device class
- 2
- Regulation number
- 862.1085
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- N. Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube Catalog Number: NEA104 For in-vitro di recall (Z-1206-03) | Perkinelmer Life Sciences, Inc. | 2003-09-12 |
| Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube Catalog Number: NEA105 For in-vitro di recall (Z-1207-03) | Perkinelmer Life Sciences, Inc. | 2003-09-12 |