CARESIDE ANALYZER— 510(k) K980056
Substantially EquivalentExigent Diagnostics, Inc.
FDA 510(k) clearance K980056 for CARESIDE ANALYZER, Substantially Equivalent on 1998-03-06. Applicant: Exigent Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Exigent Diagnostics, Inc.
- Product code
- Code JJF
- Device class
- Class 1
- Regulation
- 21 CFR 862.2170
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
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