QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS— 510(k) K042446
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K042446 for QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS, Substantially Equivalent on 2004-11-02. Applicant: Bio-Rad Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code JJW
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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