DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
FDA 510(k) clearance K943397 · decided 1995-02-13
Clearance details
- K-number
- K943397
- Device name
- DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-14
- Decision date
- 1995-02-13
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- CJM
- Device class
- 2
- Regulation number
- 862.1045
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Webster, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.