RSL (125I) ALDOSTERONE KIT
FDA 510(k) clearance K862204 · decided 1986-09-25
Clearance details
- K-number
- K862204
- Device name
- RSL (125I) ALDOSTERONE KIT
- Applicant
- Radioassay Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-10
- Decision date
- 1986-09-25
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- CJM
- Device class
- 2
- Regulation number
- 862.1045
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Carson, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.