URISCREEN— 510(k) K981084
Substantially EquivalentDiatech Diagnostics,Inc.
FDA 510(k) clearance K981084 for URISCREEN, Substantially Equivalent on 1998-10-07. Applicant: Diatech Diagnostics,Inc.. Device class: 1.
Clearance details
- Applicant
- Diatech Diagnostics,Inc.
- Product code
- Code JXA
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
Recent devices under product code JXA
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