CARESIDE ALBUMIN— 510(k) K980041
Substantially EquivalentExigent Diagnostics, Inc.
FDA 510(k) clearance K980041 for CARESIDE ALBUMIN, Substantially Equivalent on 1998-02-04. Applicant: Exigent Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Exigent Diagnostics, Inc.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
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