MICRO21 WITH URINE SEDIMENT ANALYSIS— 510(k) K982301
Substantially EquivalentTriangle Biomedical Sciences, Inc.
FDA 510(k) clearance K982301 for MICRO21 WITH URINE SEDIMENT ANALYSIS, Substantially Equivalent on 1998-08-07. Applicant: Triangle Biomedical Sciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Triangle Biomedical Sciences, Inc.
- Product code
- Code JOY
- Device class
- Class 2
- Regulation
- 21 CFR 864.5260
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Beach Gardens, FL, US
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More clearances from Triangle Biomedical Sciences, Inc.
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