FLEXSURE OBT— 510(k) K961062
Substantially EquivalentSmithkline Diagnostics, Inc.
FDA 510(k) clearance K961062 for FLEXSURE OBT, Substantially Equivalent on 1996-11-06. Applicant: Smithkline Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Smithkline Diagnostics, Inc.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sharon Hill, PA, US
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