DSL BETA 2 MICROGLOBULIN (DSL 6200)
FDA 510(k) clearance K911881 · decided 1991-09-10
Clearance details
- K-number
- K911881
- Device name
- DSL BETA 2 MICROGLOBULIN (DSL 6200)
- Applicant
- Diagnostic Systems Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-29
- Decision date
- 1991-09-10
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- JZG
- Device class
- 2
- Regulation number
- 866.5630
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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.