CORTISOL SYSTEM BY EIA— 510(k) K852939
Substantially EquivalentAmerican Bioclinical, Inc.
FDA 510(k) clearance K852939 for CORTISOL SYSTEM BY EIA, Substantially Equivalent on 1985-08-02. Applicant: American Bioclinical, Inc.. Device class: 2.
Clearance details
- Applicant
- American Bioclinical, Inc.
- Product code
- Code CGR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
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