ACCESS CORTISOL ASSAY (MODIFICATION)— 510(k) K954733
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K954733 for ACCESS CORTISOL ASSAY (MODIFICATION), Substantially Equivalent on 1995-12-05. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories, 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
- Chaska, MN, US
Recent devices under product code CGR
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