N-ASSAY GLU-UL— 510(k) K980883
Substantially EquivalentCrestat Diagnostics, Inc.
FDA 510(k) clearance K980883 for N-ASSAY GLU-UL, Substantially Equivalent on 1998-09-03. Applicant: Crestat Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Crestat Diagnostics, Inc.
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
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